Senior Quality Assurance Specialist

ACTalent; Lexington (MA); On-site; USD 83,000 - 96,000; Full time

Benefits offered by this job

Medical benefits

401(k) Retirement Plan

Job summary

Actalent is seeking a Quality Assurance Specialist to oversee quality operations onsite in Lexington, MA. The role requires collaboration with QA, RA, and CMC teams to review GMP documentation and run batch disposition activities.

You will review master/executed batch records, packaging records, and lab data, ensuring data integrity and compliance with GMP. A science degree with 4+ years in FDA-regulated pharma/biotech is required.

Qualifications

• Bachelor's degree in a scientific discipline with 4+ years in FDA-regulated pharma/biotech
• Experience with biologics and cell/gene therapy products preferred
• Experience reviewing GMP manufacturing records and change controls
• Hands-on lab testing and method validation experience

Responsibilities

• Oversee quality operations at the company and at external service providers (CDMOs/CTLs)
• Review and approve GMP documentation from service providers
• Review and approve master/executed batch records and packaging records for drug substances and products
• Perform GMP raw material release activities for internal manufacturing
• Review laboratory data related to release and stability, including protocols and reports
• Collaborate with QA, RA, and CMC teams to review documents
• Review audit trails and ensure data integrity from external CDMOs/CTLs
• Support batch disposition activities and data uploads in quality systems
• Compile data for quality system reviews

Skills

Quality assurance

GMP knowledge

Collaboration

Laboratory testing

Education

Bachelor's degree in science

Job description

Quality Assurance Specialist

Description

Oversee quality operations at the company and at external service providers (CDMOs/CTLs)

Review and approve service providers' GMP documentation

Review and approve master/executed batch records and packaging records for drug substances and drug product/finished drug product

Perform GMP raw material release activities for internal manufacturing operations

Review and approve laboratory data related to the release and stability of GMP materials, qualification of test methods and reference standards, including protocols, data, and reports

Collaborate with external service providers and internally with QA, RA, and CMC teams to support the timely review and approval of documents

Review records, including audit trails, and ensure the integrity of data and results generated by external CDMOs/CTLs

Support batch disposition activities, including data upload, review, and documentation in applicable quality systems

Compile data for quality system reviews

Additional Skills & Qualifications

• Bachelors in a scientific discipline with 4+ years of experience in the FDA regulated pharmaceutical/biotech industry with GMP manufacturing operations analytical development and quality
• Experience in Biologics and Combination Products (Cell and Gene Therapy, monoclonal antibodies) is preferred
• Experience with review of GMP manufacturing records (Master/Executed batch records, change controls, deviations, investigations, change controls, product complaints) associated with clinical programs
• Hands-on experience with laboratory testing and method validation

Work Environment & Additional Details

Work Location: 100% onsite

Schedule: Monday-Friday, 100% onsite, 9:00 AM - 5:00 PM

Experience Level

Intermediate Level

Job Type & Location

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

Pay and Benefits

The pay range for this position is $60.00 - $70.00/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 18, 2026.

Workplace Type

This is a fully onsite position in Lexington,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 be 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.