Careers

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Systems Administrator II

Purpose: The purpose of the Systems Administrator II is to ensure uptime, performance, and security of computer systems primarily focused on servers, switches, routers, firewalls, and data solutions for Associates of Cape Cod, Inc.

General Responsibilities:

Perform installation, configuration, qualification, maintenance and troubleshooting of information systems, applications and related hardware and firmware
Provide technical support for both hardware and software issues to end-users
Review system logs to proactively mitigate issues and maintain security
Maintain systems documentation
Assist in periodic performance/metric reporting
Provide basic training to end-users in operation of equipment and applications
Provide on-call/after-hours support for critical computerized systems, potential weeknights, weekends and or holiday coverage
Author and maintain information technology company-wide policies
Manage and verify backup infrastructure and restoration of data
Maintain, implement, and test disaster recovery and business continuity runbooks
Assist leading and managing IT projects to support various business functions
Provide guidance to less experienced team members
This position requires travel between our East Falmouth, MA and Mansfield, MA facilities

Knowledge and Skill Requirements:

In-depth knowledge of Microsoft operating systems (Windows 11 & Server 2008-2025)
In-depth knowledge in Microsoft Server applications including IIS, Exchange and SQL In-depth knowledge of Active Directory and Group Policies In-depth understanding of computer networking concepts, protocols and services
In-depth knowledge of batch or PowerShell scripting In-depth knowledge of cloud computing platforms (Azure/AWS preferred)
In-depth knowledge of virtualization solutions (VMware ESXi, Hyper-V, and Xen preferred) Experience in Office 365
Experience with Microsoft Intune
Experience in administering Unix/Linux operating systems
Experience in administering Oracle database solutions
Knowledge of project management best practices and methodologies
Ability to research and solve complex technical issues
Detail-oriented and excellent organizational skills
Ability to effectively communicate and explain detailed and/or complicated technical issues in terms that benefit users and help resolve problems and issues
Ability to manage multiple projects and ensure deadlines are met
Ability to follow rules, regulations and guidance required in FDA and ISO regulated environments

Preferred Qualifications:

Any current technology certification (A+, Network+, Security+, MCTS, MSCA, ITIL etc.)
Information Technology Service Management tool set experience
SOX, 21 CFR Part 11, GDPR, GxP and/or HIPAA experience

Education and Experience:

A minimum of a Bachelor's degree preferably, but not required in computer science or a related field or an equivalent combination of experience and/or education required
Five or more years related experience in systems administrator, hardware maintenance such as configuring, installing and troubleshooting servers, workstations, and network related equipment
Biotechnology, life science, pharmaceutical or healthcare industry experience is preferred

General Job Competencies:

Excellent communication and listening skills
Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers
Excellent time management, planning and forward-thinking skills
Able to reach fact-based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
Self-motivated and a professional attitude
Meets deadlines, works independently, maintains focus, punctual, good attendance record
Honest, accountable, maintains confidentiality
Takes action, seeks new opportunities, and strives to see projects to completion within the job description boundaries
Keeps information organized and accessible, maintains efficient workspace, manages time well
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
Strives to understand contributing factors, works to resolve complex situations
Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement
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
Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
Effectively communicates up and down the chain of command
Looks for opportunities to increase knowledge, works to increase responsibility, and strives to achieve personal goals
Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner

Physical Requirements:

Frequently sit and stand, occasionally walk. Frequently use hands to handle or feel. Frequently reach with hands or arms. Occasionally Lift 1-50 lbs. 1-33% of the time. Carry 1-20 lbs. 1-33% of the time. Moderate noise level is typical for the work environment of this job.

Job Type: Full-Time

Salary: $88,000-$110,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate's work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover Systems Administrator II 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.

Quality Systems Specialist

Purpose: Assure compliance to ACC policies and procedures and applicable external standards. Provide recommendations to teams as they work within the different Quality System Elements, such as Design Control and investigation activities within all Quality Systems. Participate in all quality system investigations as needed, and other duties as assigned.

General Responsibilities:

Review and approve Material Specifications and Item Masters
Lead/participate in Quality Event investigations, and maintain Quality Event system
Lead investigation, corrective/preventive action and implementation of Quality Management System process improvements
Responsible for investigating and coordinating other quality system assignments (Complaints, CAPA’s, Deviations, audit findings etc.) in a timely manner
Participate in Quality Improvement Teams, Design Control Teams, and Risk Management Teams as a representative of the Quality Department
Write, revise, and train on standard operating procedures for continuous improvement
Perform Quality Assurance review of quality records, reports and data
Perform Internal Quality System Audits as assigned
Perform Supplier Quality System Audits as assigned
Participate in FDA, ISO, Internal, Customer, audits as required
Perform customer, distributor, and internal requests for quality information (i.e. paper audits, general information)
Perform effectivity/follow up to ensure that CAPA’s and other QMS changes/updates are effective
Other duties as assigned, which may include, but are not limited to:
- Department trending for reporting
- Assist in supporting the Annual Product Review program to meet company deadlines
- Coordinate Management Review activities including preparation of Quality Department metrics and organization of metrics from all other areas
- Perform training on Quality topics as needed
- Ensure non-conforming material is handled when found, per the Management of Quality Events procedure

Knowledge and Skill Requirements:

Working knowledge of cGMP, ISO 13485, and other international standards
High attention to detail and excellent organizational skills
Able to work in a fast paced team environment
High degree of critical thinking skills
Excellent oral and written communication skills
Excellent use of Microsoft Excel (graphing techniques), Word (formatting, spelling, creating tables), PowerPoint
Ability to work with others and teams to resolve quality issues and ability to work independently without supervision

Education and Experience:

A minimum of a Bachelor’s degree or equivalent combination of experience and/or education required
Must have previous QA/QC experience in a regulated environment

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

Salary: $60,000-$84,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover Quality Systems 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.

Quality Control Analyst I

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
    - Raw Materials
      - Receiving Inspection of all Raw Materials
      - Testing Raw Materials (in house/contract lab)
  - 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
    - Preparation of glassware for Laboratory use
    - Management/Handling of Hazardous Waste
- Problem Solving/Decision Making
  - 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)
  - Collaborate with Supervisor to incorporate changes/revisions to SOP’s as directed
- 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
Time Management 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 of 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
Required to pass LAL Training and Certification

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 equivalent or a combination of experience and education required.

General Job Competencies:

Create and edit documents utilizing Word, Excel, PowerPoint and LIMS
Meet deadlines, work independently, accountable, maintain focus, punctual, good attendance record
Information is organized and accessible, maintain efficient workspace, manage time well
Manage workload, work efficiently, and meet goals and objectives
Strive to eliminate errors, accurate work is a priority, compliant with quality system requirements
Maintain current understanding of technical processes/equipment

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, gowns, and facemasks is required.

Job Type: Full-Time

Salary: $49,000-$71,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate's work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

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.

Quality Assurance Specialist

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 Job 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

Salary: $60,000-$83,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate's work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover 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.

QC Laboratory Assistant

Purpose: Performs general laboratory duties 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. Employee has working knowledge of relevant policies and procedures to perform QC tasks and document results. Employee receives minimal supervision on routine assignments and detailed instructions on new assignments.

General Responsibilities:

Responsibilities include performance of general laboratory tasks per approved procedures. Tasks may include (but are not limited to):

Prepare glassware for laboratory use -washing, foil wrapping and depyrogenation
Maintain laboratory inventory including ordering, transferring, and storing all samples, chemicals, and reagents
Review and replace temperature charts in the QC Laboratory
Identify samples for disposal and follow correct/appropriate disposal procedure which includes biohazard waste
Manage Satellite Accumulation Areas
Chain of Custody Management for samples, including labeling
Collect water, environment or QC samples as required
Data entry: record data in a timely manner, as defined in performance objectives, ensuring all documentation is accurate and complete
Cleaning (including but not limited to: classified areas, equipment, controlled chambers.)
Raw Material measurements
Perform inspection of all raw materials to verify conformance with specified requirements
Receive samples and process using internal LIMS
Problem Solving/Decision Making
Contribute to discussions with the team to meet group goals
Identify basic laboratory issues. Alert Supervisor and make detailed observations in support of investigations
Planning
Plans execution of 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.
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:

Strong organizational skills
Time management skills
Must be detail oriented
Ability to work independently, as well as, with others in a fast-paced laboratory environment
Good oral communication skills
Working knowledge of cGMP and internal standard operating procedures and policies, and universal precautions

Education and Experience:

High school diploma or equivalent or a combination of experience and education required

General Job Competencies:

Competent in the use of Word and Excel
Meet deadlines, work independently, accountable, maintain focus, punctual, good attendance record
Information organized and accessible, maintain efficient workspace, manage time well
Manage workload, work efficiently, and meet goals and objectives
Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
Builds strong relationships, is flexible/adaptable, work well with others, solicits feedback

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 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. 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, gowns, and facemasks is required.

Job Type: Full-Time

Salary: $20.00 per hour
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate's work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover QC Laboratory Assistant 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.

Logistics Technician - Packaging

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:
- 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:
- 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

Salary: $22.00 per hour
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate's work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

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.

Temporary LAL Production Technician

Biotech on Cape Cod! ATTN Students & Job Seekers!
Looking for a great opportunity to gain hands-on experience in a biotech, FDA-regulated facility? This is the place for you! We are seeking hardworking, motivated, and reliable individuals to join our LAL Production team. This is a fast-paced environment where you’ll work alongside a team that shares a common goal, making it a great place to learn, grow, and gain valuable experience in the biotech field. This opportunity is perfect for students, recent grads, or anyone looking to gain experience or try something new. Internships are available, along with seasonal opportunities from May through November. Full-time and part-time options are available. Must be 18 years of age or older.

Purpose: Responsible for all functions related to Horseshoe Crab bleeding and processing.

General Responsibilities:

Receiving crabs and unloading barrels of crabs from trucks
Bleeding crabs, initial cell processing, and operation of centrifuges
Washing and preparing all bleed related glassware
Assisting with preparation of Production glassware
Cleaning all bleed related rooms
Other duties as assigned by supervisor

Knowledge and Skill Requirements:

English language skills
Able to lift up to 25 lbs.

Education and Experience:

Minimum of 3 years of high school, or more; 1 yr. of college preferred or an equivalent combination of experience and/or education required

General Competencies:

Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
Honest, accountable, maintains confidentiality
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
Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

Occasionally sit. Constantly stand, frequently walk. Constantly use hands to finger, handle or feel. Frequently reach with hands or arms. Occasionally climb or balance. Constantly talk or hear. Occasionally taste or smell. Lift 26 to 50 lbs, 1-33% of the time. Carry 11-25 lbs, 1-33% of the time. Occasionally exposed to wet or humid conditions (non-weather). Occasionally work near moving mechanical parts. Frequently exposed to toxic or caustic chemicals. Occasionally exposed to outdoor weather conditions. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time and/or Part-Time

Salary: $18.00-$19.00 per hour

To Apply:

Please submit a current resume and cover Temporary LAL Production Technician (May-November) 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.

Supervisor, Document Control

Purpose: Maintain document control systems and activities; administration of the electronic Quality Management Systems (eQMS); manage support activities for eQMS; manage training within the Learning Management System (LMS). Manage Document Control functions and activities.

General Responsibilities:

System Administrator for the electronic Quality Management Systems (eQMS)
Manage support activities for eQMS
Manage all document control activities per procedure
Responsible to ensure that the ACC document control system and training program is in compliance with all applicable standards and guidelines
Manage training within the Learning Management System (LMS)
Maintain document control databases such that they are up to date and accurate at all times
Perform training as required
Review, approve and release Quality Records such as product history records and manufacturing records and certificates as needed
Prepare for and participate in customer, regulatory and internal audits
Support the generation monthly metrics and reports as needed
Participate in project teams and change controls as the Document Control representative
Participate in change management process
Other duties as assigned

Knowledge and Skill Requirements:

Working knowledge of cGMP, ISO 13485, IVDD, IVDR and other international standards and guidances and principles of document control
Detail oriented and excellent organizational skills
Ability to work in a 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

Education and Experience:

5 years' experience working within a quality system and regulated environment
3+ years working in a Documentation Control function preferred
A minimum of a Bachelor's degree or equivalent combination of experience and/or education required

General Job Competencies:

Communicates well (written and verbal), delivers presentations, and 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
Meet deadlines, works independently, accountable, maintains focus, punctual, good attendance record
Honest, accountable, maintains confidentiality
Information, organized and accessible, maintains efficient workspace, manages time well
Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
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

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.

Job Type: Full-Time

Salary: $65,000-$91,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

To Apply:

Please submit a current resume and cover Supervisor, Document Control 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.

Boiler Operator

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

Salary: $64,000-$67,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

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.

Facilities Mechanic

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

Salary: $50,000-$61,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

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.

Quality Control Analyst III

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

Salary: $$56,000-$79,000 a year
Pay Range Details: The pay range listed on each job posting at ACC represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

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.