Careers

Description: Work as part of a team where needed, controlling of inventory in the Finished goods and Raw material warehouses, receiving incoming packages/shipments, labeling of product, packaging final product for sale, and fulfillment of customers’ orders.

General Responsibilities:

• Shipping;
• Fulfillment of all Customers orders
• Preparation of all outgoing shipments including documentation for those shipments
• Control of all “Finished Released” product

• Receiving;
• Receives/stores all materials for ACC use
• Performs all necessary receiving transaction within Data Management System (DMS).
• Confirms accuracy of receipt against ACC documentation/Purchase Order
• Receipt of Testing Services samples
• Fulfills and completes transactions of all raw material in-house material requisitions

• Kitting/packaging;
• Assists Kitting Department as needed, in the manufacturing/packaging of finished product to be sold to customers
• All necessary DMS transactions for the above packaging process

• Labeling;
• Assists in the labeling department as needed, labeling finished products as well as in-process material

• Additional;
• In addition to the above tasks, assisting in weekly cycle counts in all areas
• Absentee coverage in all areas

Knowledge and Skill Requirements:

• Detail oriented
• Strong organizational skills
• Good communications skills
• Working computer knowledge

Education and Experience:

• High school diploma or equivalent
• Detail oriented
• Strong organizational skills
• Good communications skills
• Working computer knowledge
• IATA/DOT knowledge a plus

General Competencies:

• Able to work independently or as part of a team within a fast paced fast-paced deadline environment
• Ability to multitask
• Ability to be flexible and shift direction easily
• Ability to prioritize

Physical Requirements:

• Ability to lift at least 25 lbs.
• Ability to do repetitive jobs/movements
• Ability to work on your feet for extended periods of time

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Logistics Technician 1 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.

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

General Responsibilities:

• Provide technical support for endotoxin detection products. This includes answering questions, troubleshooting and giving assistance with protocol development for current ACC customers
• 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
• Report results to clients following cGMP standards and ACC SOP’s
• Provide technical support for Northstar products
• Receive and document customer complaints following the ACC SOP for complaints
• Visit customers when necessary to troubleshoot problems and to provide training
• Participate in company-sponsored workshops
• Provide support and training to all customers and distributors
• Maintains Customer Database - monitor progress of potential customers’ product trials; follow up with customers regularly
• Provide customer (and prospect) training courses (domestic and international)
• Plan and execute both in-house and off-site training events
• Execute Glucan detection assays
• Transmit information to customers in a clear and concise manner
• Triage customer calls and e-mails
• Calm upset callers and manage the interaction with clients
• Identify key technical issues to be addressed in client communications
• Development of technical plans to address customers’ concerns
• Provide initial employee training
• Serve as a backup to engineering to perform instrument calibrations and validations
• Writes standard operating procedures as required
• Ability to travel (25% or more)
• Required to maintain a non-expired valid passport or visa when necessary

Knowledge and Skill Requirements:

• Good public speaking skills and writing skills
• Work well in team-based assignments
• Work well under pressure in a dynamic environment
• Expert knowledge of photometric instrumentation and photometric instrumentation-related software
• Must have good laboratory skills, including pipetting and aseptic technique
• Knowledge of LAL regulations to provide customer assistance in all company areas
• Knowledge and ability to perform work in compliance with applicable cGMP and ISO regulatory 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, or microbiology
• Experience with customer database, presentation software, LAL testing instrumentation and software, Quality System controlled work environments, GMP/ISO regulated work

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
• Builds 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 Technical Services Representative here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor of Science degree 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: Associates of Cape Cod, Inc. (ACC) is a global leader in endotoxin and (1→3)-ß-D-glucan detection products and services. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents. Our endotoxin detection reagents, instruments and software are used within the Pharmaceutical, Medical-Device, Biotechnology, Compounding Pharmacy and Dialysis industries for quality control, product release and research. Our reagents are FDA licensed and can be used for testing in compliance with USP, EP and JP bacterial endotoxin test chapters. ACC also offers a clinical diagnostic product line which includes, software and instruments to support the diagnosis of Invasive Fungal Disease. The worldwide headquarters is in East Falmouth, Massachusetts.

Join us at ACC and work in a multidisciplinary environment where Biology and Medicine meet Engineering, Chemistry and Manufacturing to support the development of new endotoxin and glucan detection products. We are seeking a talented collaborative, and driven Research Associate II to join the Product Development team.

General Responsibilities:

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

• Conduct laboratory experiments and studies according to approved protocols and Standard Operating Procedures (SOPs)
• Collaborate in creating SOPs, protocols for studies, verifications, and validations
• Participate in the development, improvement, verification, validation, and technology transfer of current and new products or processes
• Analyze laboratory results and prepare study reports
• Follow Design Control requirements and SOPs in a GMP environment
• Participate in cross-functional activities
• Maintain records in accordance with Quality Assurance guidelines
• Support regulatory filings for Class I and Class II in vitro diagnostic reagents and products

Knowledge and Skill Requirements:

• Experience providing analytical support for assay development activities
• Experience working as part of a cross functional team
• Experience with reagent, instrument, and software development
• Experience collaborating with external CRO/CMOs
• Experience with change management processes
• Knowledge of basic statistics
• Experience with automation and automated processes
• Understanding of protein and enzyme function

Education and Experience:

• A BS/MS in biochemistry, chemistry, analytical chemistry, or closely related field with at least two years’ experience in industry or an equivalent combination of experience and/or education required.

General Competencies:

• Excellent written and verbal communication skills required
• Strong record keeping and organizational skills with excellent attention to detail
• Ability to work independently with minimal supervision

Physical Requirements:

• Frequently sit, frequently stand, and walk, use hands to finger, handle or feel. Frequently reach with hands or arms, occasionally climb or balance. Occasionally stoop, kneel, crouch, or crawl. Frequently talk or listen. Frequently look at detailed information on computer screens and in printed form. Occasionally lift of carry 11 – 25 lbs. Occasionally exposed to wet or humid conditions. Frequently work near moving mechanical parts. Occasionally work in high places. Occasionally exposed to fumes, airborne particles, 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 Research Associate II here.

In your cover letter please answer the following:

• Have you completed the following level of education: BS/MS in biochemistry, chemistry, analytical chemistry, or closely 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: To develop a greater understanding of the product and product potential and to effect changes in protocols to provide greater reliability and robustness with respect to these products. Additionally, to develop new concepts in endotoxin and 1,3-b-glucan testing as well as moving beyond the current lysate dependent products to related areas of potential commercial products. Provide technical expertise for the technology transfer of R&D projects into -development under quality system regulations, including Design Control requirements.

General Responsibilities:

The major responsibilities of this position will be to investigate the scientific potential for new products in Glycobiology and the detection of elicitors of innate immunity as well as providing the feasibility studies for new approaches to improve existing lysate and lysate products and a new generation of core technology.

• Included in this position is knowledge of the Quality System as well as a detailed and accurate documentation of the work
• The position will require assisting in project management within the Quality System
• As an Assistant Scientist, the individual will be expected to remain current in the literature of the field and contribute to the development of innovative products based on the current core technologies of Associates of Cape Cod, Inc.
• This individual will be expected to work in conjunction with Research Scientists as well as independently, in designing experiments and new concepts
• The position will require individual development from both internal training and extramural activities such as attending professional meetings and short courses.

Knowledge and Skill Requirements:

• Protein Chemistry/Biochemistry including enzymology, and purification techniques
• The use of spectroscopy, chromatography, [including HPLC], and immunology techniques for molecular determinations
• Basic knowledge of Assay Development
• The position will require a working knowledge of spectroscopy, chromatography, and general chemical and physical techniques
• Additionally, the position requires certification on the Endotoxin and b-Glucan assays representing the core technologies of Associates of Cape Cod, Inc.
• Ability to work within the Quality system to affect scale-up protocols, complete order fulfillment, perform necessary manufacturing and release testing, and manage technology transfer to other companies or departments

Education and Experience:

• The position requires a minimum of a B.Sc. in Chemistry, Biology or Biochemistry or an equivalent combination of experience and/or education, as well as related experience in industry at the introductory level. Knowledge of basic protocols utilized in Carbohydrate chemistry and Biochemistry, such as electrophoresis, protein purification, HPLC and Carbohydrate analysis, along with a skill set in Assay Development and quantitative analysis. This position requires an effective knowledge of project design, management and execution, within the quality system at Associates of Cape Cod, Inc.

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 Research Associate here.

In your cover letter please answer the following:

• Have you completed the following level of education: B.Sc. in Chemistry, Biology or Biochemistry?
• 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: Ensure that the Quality Management System is compliant to ISO 13485, 21 CFR 820, other applicable standards/regulations and internal procedures.

General Responsibilities:

• Review and release of batch history paperwork prior to product release to ensure all requirements are met within the required timeframe to support ACC business needs
• Review and release of kit requisitions
• Investigate, coordinate, and resolve Quality System Events in a timely manner as needed
• Participate in maintaining quality system databases and processes
• Responsible for generating metrics reports for trending and reporting mistake free paperwork for all departments
• Participate in Quality Improvement Teams as a representative of the Quality Assurance department
• Write, revise, and train on Standard Operating Procedures
• Perform CAPA and audit finding related activities as needed, including effectivity checks and follow up
• Quality Assurance review of quality records, reports, and data (Contract Test Service reports, Quality Control data, instrument calibration reports, certificates, etc.)
• Quality Assurance review of other quality records
• Performing receipt and release activities as needed (includes inspection and/or release of materials, including instruments, in the ERP system)
• Support QA inspection team as needed
• Participate in year-end inventory activities, as needed
• Conduct Quality Records Practices training for employees as required
• Perform internal quality system audits, or support the process, as needed
• Perform Supplier quality system audits, or support the process, as needed
• Complete Supplier Quality questionnaires
• Provide support for and/or lead on-site customer audits, including the processing of audit findings and follow up
• Participate in or support FDA and ISO audits as required
• Other projects and duties as assigned

Knowledge and Skill Requirements:

• Strong working knowledge of 21 CFR 820, GMP, ISO 13485
• Detail oriented and excellent organizational skills
• Ability to work in fast paced team environment
• Ability to work on multiple tasks and meet deadlines
• Excellent oral and written communication skills
• Proficiency in all office based software
• Use of Microsoft Excel (graphing techniques) and Word (formatting, spelling, creating tables). Excellent computer skills

Education and Experience:

• A minimum of a Bachelor’s degree or an equivalent combination of experience and/or education required
• A minimum of 2 years’ experience in an FDA regulated industry, biotech or other related industry or equivalent experience
• Experience with audits preferable

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Communicates well (written and verbal), delivers presentations, has good listening skills
• Performs 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
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Honest, accountable, maintains confidentiality
• Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
• Information organized and accessible, maintains efficient work space, manages time well
• Strives to understand contributing factors, works to resolve complex situations
• Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices
• 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, occasionally stand, and frequently walk. Occasionally use hands to finger, handle or feel. Occasionally reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch or crawl. Constantly talk. Lift 11 to 25 lbs, 1-33% of the time. Carry 11 to 25 lbs, 1-33% of the time. Occasionally exposed to toxic or caustic chemicals.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Quality Assurance Specialist 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: Responsible for ensuring that the equipment and instrument calibration program operates according to internal cGMP, ISO 13485 and other applicable national and global requirements.

General Responsibilities:

• Follow procedures to perform basic calibration of temperature, pressure, time and speed instrumentation
• Provide outstanding support to internal instrument owners
• Coordinate with instrument owners to confirm monthly calibration schedules are completed by performing calibration and coordinating with calibration vendors
• Send instruments to be calibrated offsite and track their status until their returned
• Review, approve and file calibration documentation
• Independently work within the filter certification program including, scheduling, coordinating, as well as reviewing and filing of all certification documentation
• Enter calibration information into database and ensure database accuracy
• Provide support for facility related activities varying in nature

Knowledge and Skill Requirements:

• Experience performing basic calibration of temperature, time, pressure instruments
• 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
• Previous experience as an administrative assistant or in administrative role is preferred

Education and Experience:

• A minimum Associate’s degree in a technical discipline or an equivalent combination of experience and education required. Previous experience in a regulated environment strongly desired.

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 sit. Occasionally 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.
• Occasionally exposed to wet or humid conditions (non-weather). Occasionally 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 for this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Calibration Technician here.

In your cover letter please answer the following:

• Have you completed the following level of education: Associate'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 provide scientific and supervisory oversight of CTS Analysts/Research Analyst/Laboratory Assistant and their documentation related to the studies conduct for contracted clients of CTS (60% of position). Perform LAL testing and/or method development/validation on samples received in CTS based on USP <85>/<161> standards, cGMP, and ACC standard operating procedures (SOP) (40% of position).

General Responsibilities:

• Daily supervision of CTS Analysts/Laboratory Assistant/Research Analysts
• Peer review of data packages for clients for scientific correctness and compliance with the USP <85>/<161> standards, ACC SOPs, and cGMP
• Review of: monthly pipette verification, weekly temperature charts, monthly plate reader verifications, monthly cleaning logs and annual recertification of analysts
• Review and implement changes to CTS SOPs to address audit findings and to maintain compliance with the current USP standards and cGMP
• Review monthly tracking/trending of metrics within CTS
• Provide solutions/idea for process improvement in CTS
• Maintain a working relationship with Quality in order to improve data packages, reports, and SOP’s
• Provide support to CTS Analyst in their interactions with clients answering testing, regulatory, and pricing questions
• Provide support during onsite client audits and/or regulatory audits
• Coordinate testing priorities for clients with RUSH and STAT requests
• Provide oversight for study cost on research projects (projected cost, actual cost and invoiced cost)
• Conduct performance reviews of CTS Analysts and provide support to the CTS analysts with yearly objectives
• Perform testing using each of the three LAL methods (gel clot, turbidimetric, and chromogenic) as per SOP’s
• Interpret results from LAL test methods
• Perform LAL testing and/or method development/validation on samples received in CTS based on USP standards, cGMP, and ACC standard operating procedures (SOP)
• 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
• Report results to clients following cGMP standards and ACC SOP’s
• Provide quotation to clients as assigned
• Be able to answer complex sample questions presented by clients when the department head is not available
• 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
• Train new employees on laboratory test methods, procedures and policies
• Provide technical resources to clients and other departments
• Maintain certification in all three LAL methods
• Use appropriate procedures for laboratory and biohazard waste
• Attend training as scheduled by ACC
• Other duties as assigned

Knowledge and Skill Requirements:

• Strong organizational skills
• Excellent managerial and time management skills
• Strong team skills
• Strong leadership skills
• Must be detail oriented and have good aseptic/laboratory technique
• Ability to work independently, as well as, with others in a fast paced laboratory environment
• Excellent oral and written communication skills
• Working knowledge of cGMP, USP <85>/<161>, ISO 13485, and internal standard operating procedures and policies
• Other – Hepatitis B vaccination

Education and Experience:

• A minimum of a Bachelor’s Degree in Chemistry, Biochemistry or a related science or an equivalent combination of experience and/or education required of 10 or more years of experience in the biotech, pharmaceutical or related contract service industry with at least 7 years supervisory experience.

General Competencies:

• Offers feedback and coach’s employees appropriately, rewards employees wisely, takes mentoring role, challenges and develops employees, offers opportunity
• 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
• Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices
• 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

Physical Requirements:

• Constantly sit, occasionally stand, and walk. Frequently use of hands to finger, handle or feel. Frequently reach with hands or arms. Constantly talking and listening. Frequent exposure to fumes or airborne particles. Frequent exposure to toxic or caustic chemicals, frequent exposure 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 CTS Associate Manager 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: Biotech on Cape Cod! Seeking hardworking, motivated and reliable people for positions in our Manufacturing teams. Experience not necessary, we provide the training. Good attitude a must. Flexible shifts available 10am-6:30pm, 2pm-10:30pm and 7:30am-4pm

General Responsibilities:

• Can work in a team atmosphere and with minimal supervision
• Possess a positive attitude and desire to learn
• Work on their feet in a fast-paced environment
• Read and write English
• Have restaurant, manufacturing experience, or simply want to learn something new
• Fill and finish technicians
• Formulation of finished product
• Filling operations
• Cleaning of controlled process areas
• Glassware preparation
• Cleaning of controlled process areas
• Machine operation (crimping/filling/ Freeze dryer operation)

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 or equivalent and 0-2 years related industry experience Associates degree or equivalent is an advantage

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Production Technician 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: Assists the Finance Director as a business partner responsible for fixed asset recording, valuation, accounting, timely capitalization and reporting of the company’s fixed assets.

General Responsibilities:

• Create and monitor improved system of controls, procedures and forms for recordation of fixed assets
• Recommend any updates to accounting policies related to fixed assets
• Develop improved processes to record acquisitions and dispositions of fixed assets
• Track compilation of project costs into fixed asset accounts timely and accurately
• Reconcile subledger and general ledger asset and depreciation balances
• Investigate the potential obsolescence of fixed assets
• Conduct periodic impairment reviews of intangible assets
• Conduct physical counts and identification of fixed assets
• Prepare audit schedules relating to fixed assets and assist auditors as necessary
• Prepares journal entries, reports and adhoc requests
• Conducts analyses, provides consulting, and makes recommendations
• Actively support budget preparation, forecasts and analysis

Knowledge and Skill Requirements:

• Fixed Asset Accounting Process
• Internal Control design/improvement
• Strong Excel Skills
• Biopharma industry experience a plus
• Microsoft Dynamics Great Plains a plus
• Supports Y/E audit
• Account reconciliation and control

Education and Experience:

• +3 years Fixed Asset Accounting experience
• Bachelor's Degree in Accounting/Finance, or equivalent in experience

General Competencies:

• Reliability, integrity and commitment
• Driven, detail oriented, creative thinker
• Uses resources efficiently, strives to reduce cost, part of the budgeting process
• Excellent communication skills (written and verbal), delivers presentations, has good listening skills
• Works well with internal and external customers, 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
• Meets deadlines, works independently, accountable, maintains focus, punctual
• Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
• Information organized and accessible, manages time well
• Strives to eliminate errors, assess root cause and prevent recurrence
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

• Constantly sit, frequently stand and walk. Constantly using hands to finger, handle or feel. Constantly reach with hands or arms. Occasionally stoop, kneel, crouch, and or crawl. Constantly talk or hear. Lift approximately 1-10 lbs., 1-33% of the time. Carry 1-10 lbs., 1-33% of the time. The work environment for this job is very quiet.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Senior Fixed Asset Accountant 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: Work as part of the Quality Assurance Team to ensure the highest quality product in compliance with internal procedures, cGMP’s 21 CFR 820 and ISO 13485.

General Responsibilities:

• Inspection of finished product to meet internal procedures and customer requirements
• Level 1 and 2 inspection of raw materials per applicable material specifications
• Write and revise procedures as necessary
• Assist with audits (customer, FDA, and ISO) in the knowledge area of inspection activities
• Ensure non-conforming material is handled per applicable procedure
• Ensure quarantine areas are orderly and items are properly labeled to its status, when applicable
• Ensure timely trending of inspection data
• Product label verification per applicable procedures
• Inspection of kits using ANSI/ASQZ1.4-2003 and applicable procedures
• Quality assurance review of quality records (i.e. charts, and other associated quality records)
• Other duties as assigned

Knowledge and Skill Requirements:

• Use of Microsoft Word, Excel and Microsoft Outlook
• Experience in performing quality inspections.
• Slight lifting may be required

Education and Experience:

• High school diploma and two years inspection experience or the equivalent combination of experience combination of experience and/or education required

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
• Communicates well (written and verbal)
• Good listener, committed to finding solutions to problems, works well with difficult people
• 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

Physical Requirements:
Occasionally sit, constantly stand and walk, constantly use hands to finger, handle, or feel. Constantly reach with hands or arms, frequently climb or balance, occasionally stoop, kneel, crouch, or crawl. Constantly talk or listen, occasionally taste or smell. Lift 11 to 25 lbs. 1-33% of the time, carry 11to 25 lbs, 1-33% of the time. Occasionally exposed to working near moving mechanical parts. Frequently exposed to fumes or airborne particles or toxic or caustic chemicals. 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 Quality Inspector 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.

Grow your career in life sciences on Cape Cod!

In this role you will perform 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 cGMP, ACC SOPs, and FDA 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.

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.

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

• How many years of Quality Control experience do you have?
• 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: Responsible for the oversight and labeling of all sub-assembly and make-type finished goods, and miscellaneous labels as required.

General Responsibilities:

• Responsible for the oversight of all labeling processes as well as carrying out the procedures
• Responsible for all product in label Work-In-Process (WIP)
• Label all products that require labeling in a timely manner so as not to disrupt the flow of product through the system
• Generation as needed of labels for picking tickets
• Collaborate in the label design process
• May be required to collaborate, maintain, and update labeling associated procedures
• Assist in internal and external audits as needed
• Assure that all labeling processes are carried out in a cGMP manner

Knowledge and Skill Requirements:

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

Education and Experience:

• A minimum of a high school diploma or an equivalent combination of experience and/or education requirement
• 4-plus years labeling experience preferably in a GMP/ISO environment

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
• Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
• 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, gets the job done in a timely manner

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. Frequently 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 letter for Senior Labeling Technician 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: 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: PhD in Chemistry, Biochemistry or 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.