Job Description
Job DescriptionQuality Assurance Specialist II
Location: Onsite, Norwood, MA
Schedule: First Shift | Sunday–Wednesday
Industry: Biotechnology / Biopharmaceutical Manufacturing
About the Role
We are seeking a Quality Assurance Specialist II to support GMP manufacturing operations through quality oversight, batch record review, materials disposition, documentation control, and quality systems management. This role will partner closely with Manufacturing, Quality Control, and cross-functional teams to ensure compliance with cGMP regulations, internal procedures, and regulatory requirements.
The ideal candidate will have experience in a regulated environment and a strong understanding of quality systems, batch record review, deviation management, and GMP documentation.
Key Responsibilities
- Perform quality review and disposition activities for Plasmid, Drug Substance, and Drug Product manufacturing operations.
- Review and approve executed electronic and paper batch records to ensure compliance with cGMP requirements.
- Evaluate manufacturing deviations, investigations, and documentation to ensure adherence to quality standards and procedures.
- Provide real-time quality oversight of manufacturing operations, including observation of production activities and cleanroom practices.
- Author, review, and revise SOPs, policies, batch records, training materials, and other GMP documentation.
- Support raw material review, release, rejection, and destruction processes.
- Monitor manufacturing processes to ensure compliance with approved specifications and procedures.
- Identify, document, classify, and escalate quality events and deviations as appropriate.
- Participate in internal audits and support inspection readiness activities.
- Serve as a quality representative on cross-functional teams and quality-focused initiatives.
- Lead and manage projects from initiation through completion while collaborating with multiple stakeholders.
- Drive continuous improvement efforts that enhance compliance, quality, and operational efficiency.
- Support training compliance and promote adherence to data integrity principles.
- Act as a subject matter expert (SME) and mentor for new team members.
- Assist in root cause analysis, problem-solving efforts, and implementation of corrective and preventive actions (CAPAs).
Required Qualifications
- Bachelor's degree in a scientific discipline or equivalent combination of education and industry experience.
- 2–5 years of experience in biotechnology, biopharmaceutical, pharmaceutical, or another regulated industry.
- Experience in Quality Assurance, Quality Systems, Documentation Control, or a related quality function.
- Strong knowledge of cGMP regulations and quality system requirements.
- Experience reviewing GMP documentation, batch records, deviations, and investigations.
- Excellent organizational, communication, and problem-solving skills.
Preferred Qualifications
- Knowledge of FDA, EU, and ICH guidelines and regulatory requirements.
- Experience with quality systems including:
- Batch Record Review
- Deviation Management
- Change Control
- CAPA Programs
- Training Compliance
- Familiarity with environmental monitoring and microbiological testing.
- Experience supporting manufacturing operations within a GMP production environment.
- Proven ability to lead cross-functional projects and manage multiple priorities simultaneously.
Key Skills
- Quality Assurance (QA)
- cGMP Compliance
- Batch Record Review
- Deviation Management
- Quality Systems
- Documentation Control
- Change Control
- CAPA
- Data Integrity
- GMP Documentation
- Manufacturing Quality Oversight
- Audit Support
- Project Leadership
- Training Compliance
Experience Level
Mid-Level (2–5 Years)
This is an excellent opportunity for a quality professional looking to expand their impact within a fast-paced biopharmaceutical manufacturing environment while helping ensure the highest standards of product quality, compliance, and patient safety.
Job Type & Location
This is a Contract position based out of Dedham, MA.
Pay and Benefits
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)
Workplace Type
This is a fully onsite position in Dedham,MA.
Application Deadline
This position is anticipated to close on Aug 10, 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 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.