Quality Assurance Specialist

Job Description

Job Description

Job Title: Quality Assurance Specialist Job Description

The Quality Assurance Specialist supports day-to-day manufacturing operations by ensuring that materials, production records, quality events, and finished products meet established quality requirements. This role works closely with Manufacturing, Supply Chain, and the broader Quality team to resolve quality issues, maintain accurate documentation, and support the timely release of raw materials and finished products. The ideal candidate is comfortable in a hands-on manufacturing environment and can balance documentation, compliance, and operational priorities while helping production teams meet customer and shipment deadlines.

• Review and approve batch records before and after production to ensure completeness, accuracy, and compliance with established procedures.
• Initiate, track, and close deviations, and support the implementation of effective corrective and preventive actions.
• Review and approve Bills of Materials to confirm appropriate materials, quantities, and specifications.
• Review Certificates of Analysis and release raw materials from Quality hold in accordance with quality standards.
• Resolve material, lot, expiration-date, and other quality-related issues within the ERP system.
• Coordinate sampling of raw materials, finished products, and water to support quality testing and compliance.
• Submit samples for third-party laboratory testing and track results to support timely product release.
• Maintain final product release documentation and tracking to ensure accurate records and audit readiness.
• Support change controls and ensure all required documentation is completed and properly maintained.
• Manage manufacturing training assignments to help ensure personnel are appropriately trained and qualified.
• Support document review, labeling activities, and Quality tasks associated with technical transfers.
• Support manufacturing compliance with ISO 9001 and create or revise documentation when gaps are identified.
• Collaborate with Manufacturing, Supply Chain, and Quality teams to resolve quality issues and support continuous improvement.

• Experience in Quality Assurance, manufacturing quality, quality systems, or a related regulated manufacturing environment.
• Experience reviewing batch records, deviations, change controls, Certificates of Analysis, or controlled documentation.
• Familiarity with raw-material controls, material release, product release, and third-party laboratory testing.
• Working knowledge of ISO 9001 or a comparable quality-management system.
• Experience using an ERP or electronic quality system to manage materials, documentation, deviations, or release status.
• Strong organizational skills with the ability to manage multiple quality activities and deadlines.
• Clear written and verbal communication skills, with the ability to collaborate effectively across Quality and Manufacturing teams.
• Strong attention to detail and the ability to identify documentation or compliance gaps.
• Comfort working in a hands-on manufacturing environment while balancing documentation, compliance, and operational priorities.

• Bachelors degree in chemistry, biology, engineering, quality, manufacturing, or a related scientific or technical discipline preferred.
• Experience with quality assurance practices such as batch record review, CAPA, and quality management systems.
• Understanding of GMP principles and their application in a manufacturing setting.
• Ability to contribute to continuous improvement initiatives and support the development of robust quality processes.

This is an onsite role based in Emeryville within a hands-on manufacturing environment focused on innovative cell culture media and modern quality practices. You will work closely with cross-functional teams in Manufacturing, Supply Chain, and Quality, using ERP and electronic quality systems to manage materials, documentation, and release activities. The environment emphasizes collaboration, documentation accuracy, and adherence to ISO 9001 and related quality standards, supporting a culture of continuous improvement and high-performance manufacturing.

This is a Contract position based out of Emeryville, CA.

The pay range for this position is $35.00 - $45.00/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)

This is a Contract position based out of Emeryville, CA.

This position is anticipated to close on Nov 19, 2026.

This is a fully onsite position in Emeryville,CA.

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 View email address on ziprecruiter.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.