Careers

Purpose: With direct supervision this individual will split duties between assisting with routine manufacturing operations for the manufacture of ACC and SKK commercial products in addition to driving a box truck, pickup and delivery duties, routine maintenance and other duties related as deemed necessary. Individual will also assist cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records. The individual will complete required training on time, demonstrate acceptable attendance as well as respect for coworkers.

General Responsibilities:

• Execution of routine pickup and delivery in a box truck with 15,000 GVW
• Assist with production operations
• Accurate record keeping
• Carry out work in a safe manner, notifying management of safety issues and risks
• Assist with scheduled cleaning of equipment/process areas
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements
• Complete required training on time
• Must be able to read and follow detailed written procedures
• Must be able to work overtime as required
• Ability to read and write English
• Pass a DOT physical exam
• Desire to learn and support laboratory activities
• Split time during peak production time May-Sept. 70% delivery driving duties. 30% Assisting in Lab, or other as determined
• Split time during off-peak production time Oct-March 20% delivery driving duties. 80% assisting in Lab, or other as needed and determined

Knowledge and Skill Requirements:

• Experience in manufacturing is desirable
• Experience driving a box truck is desirable
• Have a DOT card and/or CDL
• Must be able to get along with and respect others
• Must represent company in a professional manner when dealing with public/vendors
• Be able to comfortably lift at least 75 lbs.
• Basic computer skills needed

Education and Experience:

• A minimum of a high school diploma
• Valid MA Drivers License
• Clean driving record
• DOT card

General Competencies:

• Flexibility with hours/start-time during peak hours 5AM start during peak periods
• Must be able to work with live animals
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Honest, accountable, maintains confidentiality, good attendance
• Manages workload, works efficiently, meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

• CFrequently sit, frequently stand, and walk. Frequently use hands to, handle, and lift. Constantly reach with hands or arms, occasionally climb or balance. Frequently talk or listen. Occasionally exposed to cold occasionally exposed to heat. Occasionally exposed to uneven surface, and occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Must be able to perform job tasks while gowned.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for LAL Production Technician and Driver here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School diploma?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Perform Fungitell® testing on samples received in Beacon Diagnostic Laboratory (BDL) based on standard operating procedures to comply with CLIA, HIPPA, HITECH and other applicable national requirements.

General Responsibilities:

• Perform testing using Fungitell® Kit as per BDL's SOP's
• Interpret results from Fungitell® test method
• Be familiar with the quality policy for ACC
• Be familiar and follow the ACC safety policy
• Be familiar with and follow the standard operating procedures (SOP) for ACC and BDL
• Report results to clients following CLIA standards and BDL SOP's
• Interact with clients to determine their testing needs
• Interact with clients when their samples present problems
• Interact with clients when a sample needs to be retested
• Proper documentation of interactions with clients
• Participate in the daily activities as they pertain to the Beacon Diagnostic Laboratory, which entail, but are not limited to, analyzing patient samples, and producing reports
• Maintain certification on the Fungitell® assay
• Identify samples for disposal and follow correct/appropriate disposal procedure
• Maintain/order laboratory reagents, glassware and supplies
• Utilize calibrated/certified equipment and instrumentation - notify responsible deparents if equipment/instrumentation is out of calibration/certification
• Enter plate statistics into spreadsheet and CRM
• Prepare monthly quality reports along with corresponding documentation for the Laboratory Director's review and signature
• Perform monthly review of Beacon Shipment Receipt Log or accuracy and quality record practices
• Prepare quarterly Beacon reports along with corresponding documentation for the Laboratory Director's review and signature
• Prepare quarterly quality statistics such as serum controls and turnaround times
• Train new Beacon Staff and customers in the Fungitell method
• Other duties as assigned

Knowledge and Skill Requirements:

• Strong organizational skills
• Must be detailed oriented and have good aseptic/laboratory technique
• Ability to work independently, as well as, with others in a fast paced laboratory environment
• Working knowledge of CLIA, HIPPA, and biosafety/blood borne pathogen regulations
• Working knowledge of MS® Word and MS Excel
• Ability to work effectively with customers and all levels of internal personnel
• Excellent oral and written communication skills
• Other - Hepatitis B vaccination

Education and Experience:

• Bachelor's degree in laboratory science or clinical laboratory science from an accredited institution required or equivalent or a combination of experience and education required.
• Must have at least six to eight years of experience in a medical/hospital laboratory or clinical diagnostics.

General Competencies:

• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
• Information organized and accessible, maintains efficient work space, manages time well
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Maintains current understanding of technical/processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

• Constantly sit, frequently stand, and occasionally walk. Use hands to finger, handle or feel constantly. Frequently reach with hands or arms. Constantly talking and listening. Lift 1-10 lb. 1-33% of the time, carry 1-10 lb. 1-33% of the time. Constantly exposed to fumes or airborne particles, and toxic or caustic chemicals. Frequently exposed to vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Associate Technologist, Beacon Diagnostic Laboratory here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor's degree?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose:To maintain and monitor boiler and building systems in accordance with Massachusetts laws.

General Responsibilities:

• Properly monitor the facilities boiler in accordance with the Code of Mass. Regulations. CMR-146. This includes standing watch in a 24/7 environment on either a fixed or rotating schedule
• Make rounds every two hours of the mechanical room and the air handling room, checking for any problems with the machinery
• Performing preventive maintenance on facility equipment and production equipment as needed and in accordance with FDA and cGMP guidelines
• Troubleshoot any problems and take corrective actions for machinery, water systems and production equipment throughout the building
• Answer and troubleshoot alarms from the Building Management System
• Take water samples of the clean steam system, DPW system, and take TOC readings on the DI and Clean Steam System
• All duties assigned by supervisor

Knowledge and Skill Requirements:

• Knowledge of High Pressure Boiler Systems
• Knowledge of DI and DPW water systems
• Knowledge of HVAC Systems
• Ability to follow written and verbal instructions
• Working knowledge of cGMP, ISO 13485 and other regulatory guidelines as appropriate

Education and Experience:

• Minimum of a High School Diploma or equivalent education or a combination of experience and education required
• Second class fireman’s license or greater (required)

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
• Information organized and accessible, maintains efficient work space, manages time well
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

• Occasionally sit. Frequently stand and walk. Frequently use hands. Occasionally reach with hands or arms, climb or balance, stoop, kneel, crouch, or crawl. Occasionally talk or listen. Lift 26-50 lbs. 1-33% of the time. Carry 26-50 lbs. 1-33% of the time.
• Frequently exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally work in high places, occasionally exposed to fumes or airborne particles, occasionally exposed to toxic or caustic chemicals. Occasionally exposed to outdoor weather conditions, extreme heat (non-weather). Work environment is loud for this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Boiler Operator here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School Diploma or equivalent education?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: With direct supervision this individual will perform routine manufacturing operations for the manufacture of ACC and SKK commercial products. Individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records. The individual will complete required training on time, demonstrate acceptable attendance as well as respect for coworkers.

General Responsibilities:

• The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP) and applicable records
• Execution of routine production operations
• Record information into logbooks, forms or document records
• Carry out work in a safe manner, notifying management of safety issues and risks
• Perform scheduled cleaning of equipment/process areas
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
• Complete required training on time
• Perform standardization of equipment
• Receive and distribute supplies into the production area as necessary
• Communicate issues related to safety, quality, compliance and equipment to the Production Lead Operator and Supervisor
• Must be able to read and follow detailed written procedures
• Support machine change over activities
• Assist in the assembly and disassembly of process equipment
• Must be able to work overtime as required
• Pay attention to floor inventory levels and communicating any deficiencies to the Lead or Supervisor
• Other duties as assigned by supervisory staff

Knowledge and Skill Requirements:

• Experience in manufacturing is desirable
• Must be able to get along with and respect others
• Be able to lift at least 25 lbs.
• Basic computer skills needed

Education and Experience:

• A minimum of a high school diploma and 0-2 years related industry experience
• Associates degree or equivalent is an advantage

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Honest, accountable, maintains confidentiality
• Manages workload, works efficiently, meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

• Occasionally sit, constantly stand, and constantly walk. Frequently use hands to finger, handle, or feel. Constantly reach with hands or arms, occasionally climb or balance. Constantly talk or listen. Frequently exposed to toxic or caustic chemicals. Occasionally exposed to extreme cold (non-weather), occasionally exposed to extreme heat (non-weather). Occasionally exposed to uneven surface, and occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Must be able to perform job tasks while gowned.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Production Technician here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School diploma or equivalent?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Work as part of a team where needed, with primary focus within the Packaging Department on packaging final product for sale, controlling of inventory in the Work-in-Process warehouses, and occasional secondary support within the Labeling Department.

General Responsibilities:

• Kitting/Packaging;
  • Primary duties within Kitting Department include:
    • The assembly and packaging of finished products to be sold to customers
    • Shrink-wrapping of finished packaging products using a shrink-wrapping machine
    • All necessary DMS transactions for the above packaging processes
    • Product releases from quarantine to work-in-process and finished goods warehouses
    • Assisting in monthly cycle counts in all areas
  • Assure that all packaging processes are carried out in a cGMP manner following all quality system requirements
• Labeling;
  • Secondary coverage duties are in the labeling department where this includes:
    • Labeling finished products as well as in-process materials using labeling machines or by hand as required
    • Generating packaging labels and miscellaneous labels as required
    • All necessary DMS transactions for the above labeling processes
  • Assure that all labeling processes are carried out in a cGMP manner following all quality system requirements

Absentee coverage in labeling and kitting/packaging.

Knowledge and Skill Requirements:

• Ability to accurately follow procedures
• Requires attention to detail
• Ability to work alone and as part of a team
• Excellent mechanical skills and care with machinery
• Excellent communication skills
• Possess time-management skills
• Intermediate computer skills
• Excellent attention to detail and ability to maintain organized, accurate, and complete records

Education and Experience:

• High school diploma or equivalent or a combination of experience and education required
• 1-plus year of packaging/labeling/supply chain experience in a GMP/ISO environment is preferred

General Competencies:

• Strives to eliminate errors, accurate work is a priority
• Compliant with quality system requirements
• Ability to be flexible and shift direction easily
• Ability to take direction and prioritize assigned tasks
• Close interaction with a wide range of personalities

Physical Requirements:

• Sit occasionally
• Constantly stand, walk, and use hands to finger, handle, or feel
• Constantly reach with hands or arms, occasionally climb or balance, occasionally stoop, kneel, crouch, or crawl, talk or listen, occasionally smell
• Constantly looking at detailed printed information
• Lift 11 - 25 lbs 67-100% of the time, carry 26-50 lbs 1-33% of the time
• Constantly work near moving mechanical parts, occasionally work in high places, and occasionally work in extreme cold (non-weather) environment
• Frequent moderate noise is typical for the work environment of this job

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Logistics Technician - Packaging here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School Diploma or equivalent?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Perform testing on samples received in Beacon Diagnostic Laboratory (BDL) based on standard operating procedures to comply with CLIA, HIPPA, and other applicable national requirements.

General Responsibilities:

• Responsible for daily activities as they pertain to the Beacon Diagnostic Laboratory, which entail, but are not limited to, accessioning patient samples, analyzing patient samples, reviewing data, producing reports, and invoicing customers
• Be familiar with and follow the quality policy for ACC
• Be familiar and follow the ACC safety policy
• Be familiar with and follow the standard operating procedures (SOP) for BDL and ACC
• Report results to clients following BDL SOP’s
• Interact with clients to determine their testing needs
• Interact with clients when a sample needs to be retested
• Proper documentation of interactions with clients
• Maintain compliance with HIPPA
• Ensure that the Fungitell® test method and standard operating procedures used to test samples from Beacon Diagnostic laboratory are current and in compliance with CLIA and other applicable guidance
• Monitor compliance with the established policies and procedures to determine where improvements are needed and implement appropriate corrective and preventative actions
• Utilize calibrated/certified equipment and instrumentation – notify responsible departments if equipment/instrumentation is out of calibration/certification
• Identify samples for disposal and follow correct/appropriate disposal procedure
• Use appropriate procedures for laboratory and biohazard waste
• Attend training as scheduled by ACC
• Other duties as assigned

Knowledge and Skill Requirements:

• Excellent knowledge of CLIA, state regulations, HIPPA, and biosafety/bloodborne pathogen regulations
• Ability to work effectively with customers and all levels of internal personnel
• Detail oriented and excellent organizational skills
• Able to work in a fast-paced team environment
• Excellent oral and written communications skills
• Required to pass pipetting proficiency training and certification course
• Other – Hepatitis B vaccination

Education and Experience:

• Bachelor’s Degree in a scientific or health care discipline required or equivalent or a combination of experience and education required
• Must have at least two years experience in clinical diagnostics

General Competencies:

• Able to reach fact-based decisions, takes a thoughtful approach when considering options, seeks input from others, makes difficult decisions
• Information organized and accessible, maintains efficient work space, manages time well
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

• Constantly sit, frequently stand, and occasionally walk. Constantly use hands to finger, handle or feel. Frequently reach with hands or arms. Constantly talk or listen. Lift 1-10lbs, 1-33% of the time. Carry 1-10lbs, 1-33% of the time. Constantly exposed to fumes or airborne particles. Constantly exposed to toxic or caustic chemicals. Frequently exposed to vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Technologist, Beacon Diagnostic Laboratory here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor's degree or equivalent?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Responsible for working with the Facilities Department for support of work orders and PM activities according to internal cGMP, ISO 13485 and other applicable national and global requirements.

General Responsibilities:

• Coordinate with service requesters and as directed by supervisor for implementation of activities at an agreed upon timeframe
• Provide support to mechanics and senior mechanics as necessary
• Provide support for facility related activities varying in nature, including emergency response to events on an as needed basis
• This position requires regular travel between our East Falmouth, MA and Mansfield, MA facilities

Knowledge and Skill Requirements:

• Experience working around equipment including HVAC, boilers, water systems, etc.
• Knowledge of cGMP, ISO 13485, and quality management system requirements is preferred, but not required
• Detail oriented and excellent organizational skills
• Ability to effectively communicate across departments as well as with contracted vendors

Education and Experience:

A minimum of a Bachelor's degree in science or equivalent combination of experience and/or education required. Previous experience in a regulated environment preferred, but not necessary.

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
• Information organized and accessible, maintains efficient work space, manages time well
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

• Frequently stand and walk. Occasionally sit. Frequently use hands. Frequently reach with hands or arms, climb or balance, stoop, kneel, crouch, or crawl. Occasionally talk or listen. Lift 26-50 lbs 1-33% of the time. Carry 26-50 lbs 1-33% of the time.
• Routinely exposed to wet or humid conditions (including weather). Routinely work near moving mechanical parts. Occasionally work in high places, occasionally exposed to fumes or airborne particles, occasionally exposed to toxic or caustic chemicals. Occasionally exposed to outdoor weather conditions and extreme heat (non-weather). Work environment is quiet to loud for this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Facilities Technician here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor's degree in science or equivalent?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Works in the Clinical Diagnostics Group of Technical Services Department and supports all of its functions with respect to ACC Clinical Diagnostics products and services, trouble-shooting, technical advice, training, instrumentation and software support to internal staff, customers and distributors.

General Responsibilities:

• Provide technical support for Clinical Diagnostics products (e.g. Fungitell and Fungitell STAT). This includes answering questions, troubleshooting for current ACC customers and distribution network
• Knowledge of relevant instrumentation and software
• Troubleshoot/triage issues, problems and complaints in a timely manner, documenting them in CRM and providing trending to manager. Frequent follow up on all issues ensuring timely resolution of the customer’s issue
• Calm upset end users and manage the interaction with clients
• Identify key technical issues to be addressed in client communications
• Transmit information to customers in a clear and concise manner
• Proper documentation of client interactions
• Maintains Customer Database - monitor progress of potential customers’ product trials; follow up with customers regularly
• Visit customers when necessary to troubleshoot problems
• Participate in onsite or offsite workshops as needed
• Participate in internal trainings
• Documented proficiency with instrument calibrations and software validations
• Perform instrument calibrations and validations
• Participate in laboratory testing, software evaluations and projects as needed
• Ability to travel (25% or more)
• Obtain further training in areas identified by Manager, Technical Services

Knowledge and Skill Requirements:

• Excellent communication skills
• Demonstrated ability to speak in public forums
• Work well in team-based assignments
• Work well under pressure in a dynamic environment
• Knowledge product-related softwares and instrumentation
• Knowledge of Microsoft SQL database
• Must have good laboratory skills, including pipetting and aseptic technique
• Knowledge of clinical expectation and practices
• Knowledge and ability to perform work in compliance with requirements
• Required to pass a pipetting proficiency training and certification course

Education and Experience:

• A minimum of a Bachelor of Science degree or an equivalent combination of experience and/or educational requirement
• Concentration in biochemistry, chemistry, clinical microbiology
• Experience with customer database, presentation software, instrumentation and software, Quality System controlled work environments

General Competencies:

• Communicates well (written and verbal), delivers presentations, has good listening skills
• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers
• uilds strong relationships, is flexible/adaptable, works well with others, solicits feedback

Physical Requirements:

• Constantly sitting, occasionally walking, standing and using hands to finger, handle or feel
• Occasionally reaches with hands or arms. Constantly talking and listening. Lift 26 to 50 lbs occasionally; carry 11 to 25 pounds occasionally. The work environment for this job is quiet

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Clinical Diagnostic Specialist here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor of Science degree or equivalent?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Perform a wide variety of duties in connection with the installation, repair and maintenance of building, grounds, and facility equipment.

General Responsibilities:

• Properly monitor the facilities boiler in accordance with the Code of Mass. Regulations, CMR-146. This includes standing watch in a 24/7 environment on either a fixed or rotating schedule
• Make rounds every two hours of the mechanical room and the air handling room, checking for any problems with the machinery
• Responsible for monitoring Process and Utility systems and equipment to ensure continuous efficient and reliable operations
• Performs scheduled and corrective maintenance of complex equipment and systems. Evaluates equipment performance and recommends improvements to the Maintenance program and system design
• Ensure compliance with quality system procedures related to the Facility equipment and general day to day operations
• Performs scheduled and corrective maintenance of Purified Water, Clean Steam, WFI, and Process Gasses. Maintain critical facility utilities such as boilers and steam distribution systems, air compressors and other utilities
• Coordinates maintenance activities with manufacturing supervisors. Solicits quotations and reviews contractors’ proposals within his area of responsibilities
• Performs periodic inspections and conducts maintenance per procedure to prevent failure of various equipment and systems
• Performs duties with limited supervision and has the ability to work independently or in a team environment. Also has the ability to work extended hours as required
• Troubleshoot and repair electro mechanical equipment of all types, including HVAC systems
• Accurately and legibly document detailed description of work performed in equipment log books
• Develop and or revise GMP and non GMP maintenance documentation (SOPs, preventative maintenance check-lists, etc.)
• Properly monitor the facilities boiler in accordance with the Code of Mass. Regulations. CMR-146
• All other duties assigned by Facilities supervisor and/or manager

Knowledge and Skill Requirements:

• Knowledge of High Pressure Boiler Systems
• Knowledge of DI and DPW water systems
• Knowledge of HVAC Systems
• Ability to follow written and verbal instructions
• Working knowledge of cGMP, ISO 13485 and other regulatory guidelines as appropriate

Education and Experience:

• A minimum of an Associate's Degree from two-year College or technical trade school or an equivalent combination of experience and/or education required
• Five or more year’s field experience, including electrical and mechanical troubleshooting and repair
• Equivalent professional experience may be substituted in lieu of education, especially if within the field service industry for HVAC
• Universal refrigeration license and experience with the life science industry are both a big plus
• Ability to obtain a Massachusetts Second Class Fireman’s License or Special License to Operate within 1 yr is a must

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Perform tasks with a computer. Email, research, and interact with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
• Information organized and accessible, maintains efficient work space, manages time well
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

• Occasionally sit, frequently stand and walk, and use hands. Frequently reach with hands or arms, climb or balance, stoop, kneel, and crouch, or crawl. Frequently talk or listen. Lift 26 to 50 lbs 1-33% of the time. Carry 26 to 50 lbs 1-33% of the time. Occasionally exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally work in high places, occasionally exposed to fumes or airborne particles, occasionally exposed to toxic or caustic chemicals. Occasionally exposed to outdoor weather conditions. Occasionally exposed to extreme heat (non-weather). Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Facilities Mechanic here.

In your cover letter please answer the following:

• Have you completed the following level of education: Associate's Degree from two-year College or technical trade school or equivalent?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: With direct supervision this individual will split duties between assisting with driving a box truck, pickup and delivery duties, routine maintenance, in addition to miscellaneous tasks such as washing glassware, stocking gowning materials and other duties related as deemed necessary. Individual will also assist in cGMP operations utilizing Standard Operating Procedures (SOP), and applicable records. The individual will complete required training on time, demonstrate acceptable attendance as well as respect for coworkers.

General Responsibilities:

• Execution of routine pickup and delivery
• Assist with washing glassware, stocking gowning materials, and other duties as deemed necessary
• Accurate record keeping
• Carry out work in a safe manner, notifying management of safety issues and risks
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements
• Complete required training on time
• Must be able to read and follow detailed written procedures
• Must be able to work overtime as required
• Ability to read and write English
• Desire to learn and support laboratory activities
• Split time during peak production time May-Sept. 60% delivery driving duties. 40% Assisting in other duties as deemed necessary

Knowledge and Skill Requirements:

• Experience driving a box truck
• Must be able to get along with and respect others
• Must represent company in a professional manner when dealing with public/vendors
• Be able to comfortably lift at least 75 lbs.

Education and Experience:

• A minimum of a high school diploma
• Valid MA driver's license
• Clean driving record
• DOT required

General Competencies:

• Flexibility with hours/start-time during peak hours 5AM start during peak periods
• Must be able to work with live animals
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Honest, accountable, maintains confidentiality, good attendance
• Manages workload, works efficiently, meets goals and objectives
• Compliant with quality system requirements
• Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

• Frequently sit, frequently stand, and walk. Frequently use hands to, handle, and lift. Constantly reach with hands or arms, occasionally climb or balance. Frequently talk or listen. Occasionally exposed to cold occasionally exposed to heat. Occasionally exposed to uneven surface, and occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Must be able to perform job tasks while gowned.

Job Type: Temporary - Full-Time

To Apply:

Please submit a current resume and cover Temporary LAL Production Truck Driver and Glasswasher here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School diploma or equivalent?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose:

Job level is based on level of experience.

In this role, you will manage two contract testing laboratories and 20 employees:

• Contract Test Service, a laboratory specializing in testing for endotoxin and glucan contamination to support pharmaceutical and medical device manufacturers
• Beacon Diagnostics Laboratory, a CLIA-certified reference laboratory specializing in (1→3)-β-D-glucan and serum galactomannan (GM) antigen testing to support the diagnosis of Invasive Fungal Disease

General Responsibilities:

The major responsibilities of this position will be to support the advancement of the company product development pipeline.

• Responsible for ensuring that personnel, methods, and standard operating procedures comply with FDA cGMP, ISO 13485, CMS CLIA (along with applicable state department of health regulations), and other applicable national and global requirements
• Manage, mentor, coach and develop direct staff to meet and exceed individual, departmental and divisional goals ensuring alignment with corporate objectives
• Oversee customer interactions including contract, method development, communication of testing results, response to inquiries and management of customer audits
• Manage budget and expenses for the two contract testing laboratories
• Participate in strategic planning for future business growth
• Oversee implementation of new training, compliance, software programs and improvement initiatives
• Oversee verification and validation of new testing assays for addition to Testing Service Menus
• Establish departmental metrics for products and processes, trend and report to management including measures of customer satisfaction metrics
• Other duties as assigned

Knowledge and Skill Requirements:

• Excellent knowledge of FDA cGMP, ISO 13485, CMS CLIA and good laboratory practice
• Ability to work effectively with customers, sales and marketing and all levels of internal personnel
• Strong management and training skills
• Strong project management skills
• Detail oriented and excellent organizational skills
• Able to work in a fast-paced team environment
• Excellent oral and written communication skills

Education and Experience:

• A minimum of a master’s degree in a scientific or health care discipline, an equivalent combination of experience and/or education required, or an equivalent combination of experience and/or education required; advanced degree a plus. Must have at least ten years of experience in the medical device, biotech or pharmaceutical industry. Experience in managing in a contract test service environment required. Must have at least ten years of management experience.

General Competencies:

• Uses resources efficiently, strives to reduce cost, part of the budgeting process
• Communicates well (written and verbal), delivers presentations, has good listening skills
• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Good listener, committed to finding solutions to problems, works well with difficult people
• Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers
• Able to reach fact-based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
• Honest, accountable, maintains confidentiality
• Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
• Takes action, seeks new opportunities, and strives to see projects to completion within the boundaries of the job description
• Creative, offers new ideas, risk taker, amenable to change
• Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
• Provides strong leadership, sets a good example, skilled decision maker, motivator, encourager
• Information organized and accessible, maintains efficient workspace, manages time well
• Strives to understand contributing factors, works to resolve complex situations
• Manages workload, works efficiently, and meets goals and objectives
• Monitors status of projects, thoroughly deals with project details, holds project owners accountable, and delivers clear, accurate depiction of status
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Accountable to team, works to meet established deliverables, appreciates view of team members, respectful
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

• Frequently sit, stand and occasionally walk. Use hands to finger, handle or feel occasionally. Reach with hands or arms, climb or balance, stoop, kneel, crouch and or crawl occasionally. Constantly talking and listening. Occasionally taste or smell. Infrequently exposed to toxic or caustic chemicals. Work environment for this job is very quiet.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Manager/Director, Analytical Testing Services here.

In your cover letter please answer the following:

• Have you completed the following level of education: Master’s degree in a scientific or health care discipline, an equivalent combination?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Design and implement facility engineering projects in support of overall corporate objectives.

General Responsibilities:

• Responsible for the design and implementation of facility engineering projects including HVAC, production equipment, building management system and capital expense projects
• Provide expertise in research, manufacturing, engineering, design and process design/scale-up
• Assist the manufacturing/research operations in problem solving with regard to equipment and systems
• Develop capital expenditure requirements and documentation to purchase/install new systems/equipment/processes
• Develop and recommend new processes and technologies to achieve cost effectiveness and improved product quality
• Recommend processes for the production of products
• Interface with various departments (specifically manufacturing and engineering) to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology
• Support company growth with space optimization and construction management for manufacturing, research and administrative areas
• Maintain the facility drawings and ensure that applicable drawings follow change control for any modifications
• Provide assistance with annual reporting to regulatory agencies
• Perform other duties as assigned by the supervisor

Knowledge and Skill Requirements:

• Knowledge of HVAC, chilled water systems, pure water systems
• Knowledge of production equipment including autoclaves, depyrogenation ovens, filling equipment, lyophilizers, capping and labeling equipment
• Project management/team leader skills
• cGMP and ISO requirements for clean room operations

Education and Experience:

• A minimum of a Bachelor's degree in an engineering discipline or an equivalent combination of experience and/or education required
• Minimum of 5 years' experience in a manufacturing environment
• Proficient with AutoCAD
• Hands on experience with facility and production equipment including preventive maintenance and troubleshooting and resolving equipment problems

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
• Information organized and accessible, maintains efficient work space, manages time well. Manages workload, works efficiently, and meets goals and objectives
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

• Frequently sit. Occasionally stand and sit. Frequently use hands. Occasionally reach with hands or arms. Frequently talk or listen
• Lift 11-25 lbs. 1-33% of the time. Carry 11-25lbs. 1-33% of the time. The work environment of this job is quiet

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Facility Engineer here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor's degree in an engineering discipline or an equivalent?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: To develop a greater scientific understanding of the ACC/SKK product line and effect changes in protocols to give greater reliability with respect to products. To develop new products revolving around the current technology and new concepts leading to new technologies.

General Responsibilities:

• Adapt and develop new technologies around the LAL system
• Develop projects that will enhance the scientific understanding of the current products with the goal of improvement and the introduction of new products
• Expand the range of products within the framework of ACC
• Provide the technical expertise to conceptualize and implement new research areas
• Provide technical support when necessary
• Supervise Research and Development staff

Knowledge and Skill Requirements:

• Protein Chemistry/Biochemistry including enzymology and purification
• The use of spectroscopic, chromatographic and molecular biological techniques
• Assay Development
• Technology transfer and scale-up
• Supervisory experience

Education and Experience:

• A minimum of a PhD in Chemistry, Biochemistry or related field or an equivalent combination of experience and/or education required
• Several years of experience in assay development, protein chemistry and protein purification
• Additional expertise in Molecular Biology and supervisor/management experience is desired

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Uses resources efficiently, strives to reduce cost, part of the budgeting process
• Communicates well (written and verbal), delivers presentations, has good listening skills
• Perform task with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Good listener, committed to finding solutions to problems, works well with difficult people
• Works well with internal and external customer, promotes a positive image of the company, and strives to solve issues raised by customers
• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions

Physical Requirements:

• Frequently sit, frequently stand and walk, use hands to finger, handle or feel. Frequently reach with hands or arms, climb or balance. Occasionally stoop, kneel, crouch, or crawl. Frequently talk or listen. Occasionally taste or smell. Lift 11 – 25 lbs 34-66% of the time. Carry 11 – 25 lbs 34-66% of the time. Occasionally exposed to wet or humid conditions. Frequently work near moving mechanical parts. Occasionally work in high places. Frequently exposed to fumes or airborne particles, frequently exposed to toxic or caustic chemicals. Occasionally exposed to uneven surface and vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Sr. Research Scientist here.

In your cover letter please answer the following:

• Have you completed the following level of education: A minimum of a PhD in Chemistry, Biochemistry or related field ?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Performs chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Learns and executes defined QC tasks efficiently and consistently. Results are compared to specifications and documented in a timely manner. Analyst has working knowledge of relevant QC techniques, policies and procedures to perform QC tasks and document results. Analyst receives minimal supervision on routine assignments and detailed instructions on new assignments.

General Responsibilities:

• Technical Expertise
  • Demonstrated proficiency in performance of test methods, analysis of data and provide general laboratory support per approved procedures
    • Test methods may include (but are not limited to):
• Environmental Monitoring
  • Sample collection and associated testing of ISO Class 5, 7, 8, Laminar Flow Hoods, Biosafety Cabinets and critical utilities including the water systems
  • Perform Growth Promotion testing of microbiological media
  • Perform Plate reading, streaking, gram staining, and microbial ID
  • Perform Sterility Testing
• Product Release and Stability Testing
  • Perform routine Quality Control testing of raw materials, in process and final products in accordance to SOP’s
  • Performs endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic)
  • Performs Karl Fisher, pH, container closure, testing
  • Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin
  • Prepares and reviews Certificates of Analysis
  • Formulates and tests in process solutions to determine final product ratios
• Data Analysis
  • Perform calculations; interpret results and record data in a timely manner, as defined in performance objectives, ensuring all documentation is accurate and complete
• General Lab Support
  • Test sample management and handling, maintenance of lab equipment and log books, assist in ordering materials/reagents and supplies, and maintain cleanliness and safety of the laboratories
  • Participate in safety, customer, and quality audits including answering questions during tours
  • Maintain log books related to equipment and inventory, may assist in ordering of materials, reagents and supplies
• Problem Solving/Decision Making
  • Analyze and interpret study investigation results in conjunction with Supervisor. Work with Supervisor to propose next steps. Collaborate with Supervisor to implement corrective actions in response to assay and/or instrument problems
  • Contribute to discussions with the team to meet group goals
  • Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and method performance issues. Alert Supervisor and make detailed observations in support of investigations
• Planning
  • Plans execution of individual tests and activities in conjunction with Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (i.e. discussing schedule conflicts with Supervisor, ensuring all material is available for use prior to testing)
  • Prepare reports as directed by Supervisor. Collaborate with Supervisor to incorporate changes/revisions as necessary in order to generate a complete report that will be ready for upper management review
• Supervision
  • Receives minimal supervision on routine assignments. Receives specific direction on new work
  • No formal supervisory responsibility
• Perform other additional job related duties as required

Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs.

Knowledge and Skill Requirements:

• Organizational skills
• General laboratory skills
• Must be detailed oriented and show proficiency in aseptic and laboratory technique
• Ability to work independently, as well as, participate on teams comprised on immediate group members or to work cross functionally, in a fast paced laboratory environment
• Working knowledge of cGMP, ISO 13485 quality system requirements, and principles of quality control
• Required to pass a pipetting proficiency training and certification course

Education and Experience:

• A minimum B.S. degree in a relevant scientific discipline with 0-2+ years relevant laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.

General Job Competencies:

• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Information organized and accessible, maintains efficient work space, manages time well
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Frequently sit, constantly stand, walk, use hands to finger, handle, or feel. Constantly reach with hands or arms. Frequently climb or balance. Frequently stoop, kneel. Must be able to hear and communicate verbally. Lift > 25 lbs. 10% of the time above shoulder. Carry 1-10 lbs. frequently above shoulder. Occasionally exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally exposed to fumes or airborne particles. Frequently work with toxic or caustic chemicals. Occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Fine motor skills and dexterity are required in order to pipette small volumes (need a steady hand).Ability to type using a computer keyboard is required. Personnel cannot have a skin condition, upper respiratory illness, or allergic reaction that causes excessive sneezing, itching, or scratching. Exposure to the laboratory area and controlled cleanroom environments, where the use of personal protective equipment such as safety glasses, lab coats, gloves, gown, and facemasks is required.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Quality Control Analyst I here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor of Science degree?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Performs chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Results are compared to specifications and documented. Analyst has mastered most or all of the fundamental quality control concepts as well as some specialized technologies and receives minimal supervision on routine assignments. Analyzes and interprets test results independently and contributes to design of new studies in consultation with Supervisor. May provide guidance and training to more junior staff members.

General Responsibilities:

• Technical Expertise
  • Must demonstrate proficiency in performance of test methods, analysis of data and provide general laboratory support per approved procedures
    • Proficiency is defined in the individual performance objectives,
    • Test methods may include (but are not limited to):
      • Environmental Monitoring
        • Sample collection and associated testing of ISO Class 5, 7, 8, Laminar Flow Hoods, Biosafety Cabinets and critical utilities including the water systems
        • Perform Growth Promotion testing of microbiological media
        • Perform Plate reading, streaking, gram staining, and microbial ID
        • Perform Sterility Testing
      • Product Release and Stability Testing
        • Perform routine Quality Control testing of raw materials, in process and final products in accordance to SOP's
        • Perform testing of samples with increasing complexity in accordance with written protocols
        • Performs endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic)
        • Performs Karl Fisher titration for moisture
        • Performs pH determination
        • Performs container closure testing
        • Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin
        • Prepares and reviews Certificates of Analysis
        • Formulates and tests in process solutions to determine final product ratios
    • Data Analysis
      • Perform calculations; interpret results and record data in a timely manner, as defined in performance objectives, ensuring all documentation is accurate and complete
    • General Lab Support
      • Test sample management and handling, maintenance of lab equipment and log books, assist in ordering materials/reagents and supplies, and maintain cleanliness and safety of the laboratories
      • Participate in safety, customer, and quality audits including answering questions during tours
      • Maintain log books related to equipment and inventory, may assist in ordering of materials, reagents and supplies
• Problem Solving/Decision Making
  • • Analyze and interpret study investigation results in conjunction with Supervisor. Work with Supervisor to propose next steps. Propose corrective actions in response to assay and/or instrument problems to Supervisor for review prior to implementation.
    • Contribute to and when assigned lead discussions with the team (either in or out of lab meeting) to meet group goals
    • Communicates interdepartmentally and with outside contacts to solve technical issues as directed by Supervisor
    • When conducting testing, if SOP's or test methods (e.g. Method of measuring pH) are not optimal, propose ideas for development and optimization in order improve compliance, efficiency and/or reduce cost (e.g. Align current procedures with current practices, consolidate forms or procedures, recommend purchase of new equipment or instrument to upgrade or replace obsolete model). Present idea to Supervisor for approval.
    • Begins to utilize colleagues and literature to solve complex problems
    • Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and methodology problems. Alert Supervisor and make detailed observations in support of investigations.
    • Review departmental paperwork/data for compliance to procedures and specifications, identifying trends, aberrant results and potential cGMP violations to assist department as needed.
• Planning
  • • Plans sequencing of individual (or group as needed) tests and activities and communicate plan to Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (e.g. discussing schedule conflicts with Supervisor, ensuring all material is available for use prior to testing)
    • Prepare reports independently and submit to Supervisor for review. Collaborate with Supervisor to incorporate changes/revisions as necessary in order to generate a complete report that will be ready for upper management review.
• Supervision
  • • Receives overall direction from Supervisor and carries out test without supervision.
    • No formal supervisory responsibility
    • May provide training to other staff members
• Perform other additional job related duties as required

Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs.

Knowledge and Skill Requirements:

• Organizational skills
• General laboratory skills
• Must be detailed oriented and show proficiency in aseptic and laboratory technique
• Ability to work independently, as well as, participate on teams comprised on immediate group members or to work cross functionally, in a fast paced laboratory environment
• Working knowledge of cGMP, ISO 13485 quality system requirements, and principles of quality control
• Required to pass a pipetting proficiency training and certification course

Education and Experience:

• A minimum of a B.S. degree in a relevant scientific discipline w/ 2-4+ years of laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.
• M.S. degree preferred in a relevant scientific discipline w/ 0-2+ years of laboratory experience within a cGMP regulated environment.

General Competencies:

• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Information organized and accessible, maintains efficient work space, manages time well
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Frequently sit, constantly stand, walk, use hands to finger, handle, or feel. Constantly reach with hands or arms. Frequently climb or balance. Frequently stoop, kneel. Must be able to hear and communicate verbally. Lift > 25 lbs. 10% of the time above shoulder. Carry 1-10 lbs. frequently above shoulder. Occasionally exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally exposed to fumes or airborne particles. Frequently work with toxic or caustic chemicals. Occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Fine motor skills and dexterity are required in order to pipette small volumes (need a steady hand).Ability to type using a computer keyboard is required. Personnel cannot have a skin condition, upper respiratory illness, or allergic reaction that causes excessive sneezing, itching, or scratching. Exposure to the laboratory area and controlled cleanroom environments, where the use of personal protective equipment such as safety glasses, lab coats, gloves, gown, and facemasks is required.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Quality Control Analyst II here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor of Science degree?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Performs chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Results are compared to specifications and documented. Analyst is technically independent and has mastered fundamental quality control concepts as well as some specialized technologies. Independently coordinates activities with others both inside QC and outside the department and carries out projects with minimal supervision. Displays initiative and technical commitment and independence for study design. Organizes and provides written and/or oral presentations of work with minimal input from Supervisor. Displays ability to perform more complex studies and to make independent contributions to the development of new technologies. Provides guidance and training to other staff members.

General Responsibilities:

• Technical Expertise
  • Must demonstrate proficiency in performance of test methods, analysis of data and provide general laboratory support per approved procedures
    • Test methods may include (but are not limited to):
      • Environmental Monitoring
        • Sample collection and associated testing of ISO Class 5, 7, 8, Laminar Flow Hoods, Biosafety Cabinets and critical utilities including the water systems
        • Perform Growth Promotion testing of microbiological media
        • Perform Plate reading, streaking, gram staining, and microbial ID
        • Perform Sterility Testing
      • Product Release and Stability Testing
        • Perform routine Quality Control testing of raw materials, in process and final products in accordance to SOP's
        • Perform complex testing in accordance with written protocols
        • Performs endotoxin testing using LAL methods (gel clot, turbidimetric, chromogenic)
        • Performs Karl Fisher titration for moisture
        • Performs pH determination
        • Performs container closure testing
        • Perform standardization of Control Standard Endotoxin to Reference Standard Endotoxin
        • Prepares and reviews Certificates of Analysis
        • Formulates and tests feasibilities for final product ratios
    • Data Analysis
      • Perform calculations; interpret results and record data in a timely manner, as defined in performance objectives, ensuring all documentation is accurate and complete.
    • General Lab Support
      • Test sample management and handling, maintenance of lab equipment and log books, assist in ordering materials/reagents and supplies, and maintain cleanliness and safety of the laboratories
      • Participate in safety, customer, and quality audits including answering questions during tours
      • Maintain and review log books related to equipment and inventory, may assist in ordering of materials, reagents and supplies
      • May be responsible for coordination of intra and/or interdepartmental activities
      • Participate in safety, customer, and quality audits including answering questions during tours and providing written responses to audit findings as assigned
• Problem Solving/ Decision Making
  • • Technically independent and contributes substantially to the interpretation of results and design of follow up studies. Propose next steps to Supervisor for approval prior to execution. Propose corrective actions in response to assay and/or instrument problems to Supervisor for review prior to implementation
    • Contribute to and when assigned lead discussions with the team (either in or out of lab meeting) to meet group goals
    • Independently communicates interdepartmentally and with outside contacts to solve technical issues and communicates results to Supervisor
    • Proactively investigate and troubleshoot Quality Control Methods and SOP's to improve compliance, efficiency and/or reduce cost (e.g. recommend purchase of new equipment or instrument to upgrade or replace obsolete model, identify new alternative methodology/technologies , performing gap analysis to ensure alignment with cGMP or regulatory guidance's) . Present idea to Supervisor for approval
    • Utilize colleagues and literature to solve complex problems
    • Identify basic technical issues, atypical and Out of Specification results, instrument malfunctions and methodology problems. Alert Supervisor and make detailed observations in support of investigations
    • Review departmental paperwork/data for compliance to procedures and specifications, identifying trends, aberrant results and potential cGMP violations to assist department as needed
    • Represent QC at cross functional meetings as assigned in a leadership capacity (this includes disseminating information in a professional manner with the groups goals represented)
• Planning
  • • Plans sequencing of individual (or group as needed) tests and activities and communicate plan to Supervisor to ensure that assigned tasks are performed in a timely and efficient manner (e.g. discussing schedule conflicts with Supervisor, ensuring all material is available for use prior to testing)
    • Prepare reports independently and submit to Supervisor for approval. Reports should be ready for upper management review at time of submission to Supervisor
    • Prepare metrics reports including statistical analysis of results when required
    • Prepare training plans when required
• Supervision
  • • Receives overall direction from Supervisor and carries out test without supervision.
    • May supervise junior staff members
    • Provides training of other staff members
• Perform other additional job related duties as required

Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs.

Knowledge and Skill Requirements:

• Organizational skills
• General laboratory skills
• Must be detailed oriented and show proficiency in aseptic and laboratory technique
• Ability to work independently, as well as, participate on teams comprised on immediate group members or to work cross functionally, in a fast paced laboratory environment
• Working knowledge of cGMP, ISO 13485 quality system requirements, and principles of quality control
• Required to pass a pipetting proficiency training and certification course

Education and Experience:

• A minimum of a B.S. degree in a relevant scientific discipline w/ 4-6+ years of laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.
• M.S. degree preferred in a relevant scientific discipline w/ 4+ years of laboratory experience within a cGMP regulated environment.

General Competencies:

• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Information organized and accessible, maintains efficient work space, manages time well
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

Frequently sit, constantly stand, walk, use hands to finger, handle, or feel. Constantly reach with hands or arms. Frequently climb or balance. Frequently stoop, kneel. Must be able to hear and communicate verbally. Lift > 25 lbs. 10% of the time above shoulder. Carry 1-10 lbs. frequently above shoulder. Occasionally exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally exposed to fumes or airborne particles. Frequently work with toxic or caustic chemicals. Occasionally exposed to vibration. Moderate noise is typical for the work environment of this job. Fine motor skills and dexterity are required in order to pipette small volumes (need a steady hand).Ability to type using a computer keyboard is required. Personnel cannot have a skin condition, upper respiratory illness, or allergic reaction that causes excessive sneezing, itching, or scratching. Exposure to the laboratory area and controlled cleanroom environments, where the use of personal protective equipment such as safety glasses, lab coats, gloves, gown, and facemasks is required.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover Quality Control Analyst III here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor of Science degree?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.