Quality Assurance Specialist

Job Description

Job Description

Description

Provide quality oversight for manufacturing operations, ensuring compliance with cGMP regulations and internal procedures. Review and disposition raw materials, plasmids, drug substance, and drug product batches. Review and approve batch production records, testing records, and manufacturing documentation. Support batch record review and release activities for materials and products. Review, investigate, and document deviations, ensuring appropriate corrective and preventive actions are implemented. Author, review, and revise SOPs, batch records, policies, and training materials. Participate in real-time quality oversight activities within manufacturing operations and cleanroom environments. Partner with cross-functional teams to support manufacturing readiness, startup activities, and continuous improvement initiatives. Ensure adherence to data integrity principles and training requirements. Monitor manufacturing operations for compliance with established specifications and procedures. Support internal audits and regulatory inspection readiness activities. Escalate quality, manufacturing, and safety concerns as appropriate. Serve as a subject matter expert (SME) and mentor for new team members. Lead and contribute to quality and compliance-related projects across multiple functional groups. Drive root cause investigations and corrective actions for complex quality issues.

Skills

Quality assurance, drug substance, drug product, Batch record, raw materials, deviations, change control, environmental monitoring, microbioloigcal testing, Batch record review, Authoring SOPs, Sop, audit, compliance

Top Skills Details

Quality assurance,drug substance,drug product,Batch record,raw materials,deviations,change control,environmental monitoring,microbioloigcal testing,Batch record review

Additional Skills & Qualifications

BS or equalivalent experience with in science industry within quality assurance 2-5 Years experience Knowledge of FDA, EU, ICH guidelines, and relevant regulations. Experience with quality systems, including batch record review, deviation management, and change control. Proficiency in authoring and reviewing GMP documentation. Familiarity with environmental monitoring and microbiological testing.

Experience Level

Intermediate Level

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

The pay range for this position is $42.00 - $52.00/hr.

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)

This is a fully onsite position in Norwood,MA.

This position is anticipated to close on Jul 31, 2026.

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 [email protected] 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.