At least 4 years
This role is STARs-friendly: Skilled Through Alternative Routes.
73% STARs in role.
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 & LocationThis is a Contract position based out of Lexington, MA.
Pay and BenefitsThe 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)
Job Type & LocationThis is a Contract position based out of Lexington, MA.
Application DeadlineThis position is anticipated to close on Nov 18, 2026.
Workplace TypeThis 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 actalentaccommodation@actalentservices.com 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.
Posting ID: JP-006397474