Quality Assurance Specialist

Actalent; Plainville (MA); On-site; USD 39,000 - 41,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

PTO / Vacation

Transportation benefits

Health Spending Account (HSA)

Employee Assistance Program

Job summary

Actalent is seeking a Quality Specialist I for our Plainville, MA site. You will provide on-the-floor QA oversight of GMP manufacturing and review batch records for compliance and accuracy.

The role supports CAPAs, deviations, and change controls under QA guidance, partnering with manufacturing and QC to ensure adherence to SOPs and quality systems. Strong communication and GMP knowledge are essential.

Qualifications

• Minimum 1+ years of GMP industry-related experience with a Bachelors Degree in Life Sciences or Chemical/Biochemical Engineering.
• Working knowledge of FDA, EMA, and applicable GMP regulations.
• Support CAPA systems, change controls, risk management, and quality oversight.
• Understanding of GMP manufacturing operations and quality systems.
• Ability to review GMP documentation with attention to detail.
• Basic knowledge of deviations, CAPAs, investigations, and change control processes.
• Strong written and verbal communication skills.
• Effective organizational, time management, and problem-solving abilities.

Responsibilities

• Perform on-the-floor Quality Assurance oversight of GMP manufacturing operations.
• Review executed batch records and GMP documentation for accuracy, completeness, and compliance.
• Support investigations, deviations, CAPAs, and change controls under guidance from QA staff.
• Escalate quality events, compliance risks, and atypical observations in a timely manner.
• Partner with Manufacturing, QC, and support functions to ensure adherence to approved procedures.
• Support internal audits, client audits, and inspection readiness activities.
• Maintain knowledge of applicable GMP regulations, site procedures, and quality systems.

Skills

GMP experience

Documentation review

CAPA knowledge

Quality oversight

Regulatory knowledge

Attention to detail

Education

Bachelor's degree in Life Sciences or Chemical/Biochemical Engineering

Tools

Electronic quality systems

MS Office

Job description

Quality Specialist I

2 Openings

Day Shift Flex 12 Rotating

• Week 1: Monday, Tuesday, Friday, Saturday
• Week 2: Sunday, Wednesday, Thursday
• Hours: 6:45 AM 7:15 PM (30-minute lunch)

Night Shift Flex 12 Rotating

• Week 1: Monday, Tuesday, Friday, Saturday
• Week 2: Sunday, Wednesday, Thursday
• Hours: 6:45 PM 7:15 AM (30-minute lunch)

Description

The Quality Specialist I is responsible for ensuring compliance with applicable Standard Operating Procedures (SOPs), regulatory requirements (FDA, EU, ICH), and industry standards at the Plainville, MA manufacturing site.

This role provides Quality Assurance oversight and support for manufacturing and quality system activities to ensure product quality, regulatory compliance, and adherence to established quality standards. The position contributes to the maintenance and continuous improvement of the site's quality management system and quality culture through consistent application of quality processes and procedures.

Execute and Support

• Perform on-the-floor Quality Assurance oversight of GMP manufacturing operations.
• Review executed batch records and GMP documentation for accuracy, completeness, and compliance.
• Support investigations, deviations, CAPAs, and change controls under guidance from QA staff.
• Escalate quality events, compliance risks, and atypical observations in a timely manner.
• Partner with Manufacturing, QC, and support functions to ensure adherence to approved procedures.
• Support internal audits, client audits, and inspection readiness activities.
• Maintain knowledge of applicable GMP regulations, site procedures, and quality systems.

Education

• Bachelor's degree, preferably in technology, engineering, microbiology, or a related field preferred.
• Equivalent combinations of education, training, and other relevant work experience accepted.

Additional Skills & Qualifications

• Minimum 1+ years of GMP industry-related experience with a Bachelors Degree in Life Sciences or Chemical/Biochemical Engineering.
• Working knowledge of FDA, EMA, and applicable GMP regulations.
• Support CAPA systems, change controls, risk management, and quality oversight.
• Understanding of GMP manufacturing operations and quality systems.
• Ability to review GMP documentation with attention to detail.
• Basic knowledge of deviations, CAPAs, investigations, and change control processes.
• Strong written and verbal communication skills.
• Effective organizational, time management, and problem-solving abilities.
• Proficiency with electronic quality systems and Microsoft Office applications.
• Ability to identify and elevate compliance concerns appropriately.

Physical & Work Environment Requirements

• Routine presence in GMP manufacturing and controlled cleanroom environments, including required use of personal protective equipment (PPE).
• Ability to gown and work in classified manufacturing areas in accordance with site procedures.
• Frequent standing, walking, and computer-based work.
• Ability to lift up to 25 pounds occasionally.
• Visual acuity sufficient to review documentation and perform quality inspections.
• Ability to support operations during non-standard hours as business needs require.

Job Type & Location

This is a Contract position based out of Plainville, MA.

Pay And Benefits

The pay range for this position is $28.00 - $30.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Application Deadline

This position is anticipated to close on Nov 10, 2026.

Workplace Type

This is a fully onsite position in Plainville,MA.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.