Position Overview The Quality Assurance Specialist/Sr Specialist serves as a subject matter expert in GMP quality systems, compliance, and batch disposition activities. This individual will provide QA support for manufacturing operations, quality control, analytical development, and external service providers, ensuring products are manufactured and released in compliance with applicable regulatory requirements.Leveling will be determined based on experience:
- Specialist: 5-7 years of relevant experience
- Sr Specialist: 8-10 years of relevant experience
This position is based onsite in Lexington, MA, with employees working in the office five days per week.Key Responsibilities
- Provide quality oversight for internal operations and external manufacturing and laboratory partners (CDMOs and CTLs)
- Review and approve GMP documentation from external service providers
- Review and approve master and executed batch records, packaging records, and associated manufacturing documentation
- Perform GMP raw material release activities
- Review and approve laboratory data supporting release and stability programs, method qualifications, and reference standards
- Collaborate cross-functionally with Quality, Regulatory Affairs, CMC, and external partners to ensure timely document review and approvals
- Review audit trails and supporting documentation to ensure data integrity and compliance
- Support batch disposition activities, including documentation review and quality system management
- Assist with quality system assessments, metrics, and continuous improvement initiatives
- Participate in additional quality assurance activities as needed
Preferred Qualifications
- Bachelor's degree in a scientific discipline
- 5-10 years of experience in the pharmaceutical or biotechnology industry within a GMP-regulated environment
- Strong experience reviewing GMP manufacturing documentation, including:
- Batch records
- Deviations
- Investigations
- Change controls
- Product complaints
- Experience supporting clinical-stage biologics manufacturing programs
- Hands-on laboratory testing and method validation experience
- Knowledge of current GMP regulations, including:
- 21 CFR Parts 210, 211, and Part 11
- European GMP guidelines (EudraLex)
- Experience with Veeva QualityDocs and Veeva QMS
- Experience supporting biologics and combination products is highly preferred (monoclonal antibodies, cell therapies, gene therapies, etc.)
- Excellent communication and collaboration skills with both internal teams and external partners
- Strong attention to detail and a proactive, solution-oriented mindset
What We're Looking For The ideal candidate is a collaborative quality professional who thrives in a fast-paced biotech environment and brings a strong understanding of GMP manufacturing, documentation review, compliance, and batch disposition. This is an excellent opportunity to make an immediate impact while partnering with cross-functional teams and external manufacturing organizations.If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com. 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 17, 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.