Quality Assurance Specialist

Job Description

Job Description

About the Opportunity

Our client is seeking an experienced Quality Assurance Specialist to support quality operations within a regulated biotechnology manufacturing environment. This role will play a key part in ensuring product quality, regulatory compliance, and the effectiveness of the Quality Management System supporting in vitro diagnostic (IVD) products. This position is ideal for a quality professional with strong experience in batch record review, product release, ISO 13485 compliance, and quality event management.

• Perform review of batch records, QC records, raw material inspection records, calibration records, and related manufacturing documentation.
• Support lot release activities for raw materials and finished products.
• Prepare and review Certificates of Analysis as needed.
• Review and approve quality events including NCRs, CAPAs, complaints, and deviations.
• Support investigations, root cause analysis, risk assessments, and corrective actions.
• Review and approve Change Orders to ensure appropriate documentation and regulatory compliance.
• Maintain quality records and documentation in accordance with quality system requirements.
• Support internal and external audits.
• Collaborate cross-functionally with Operations, Manufacturing, and Quality teams.
• Participate in training and continuous improvement activities.

• Bachelor's degree in Life Sciences, Engineering, Business, or related discipline.
• Minimum 3 years of Quality Assurance experience in a regulated manufacturing environment.
• Experience working within ISO 13485 quality systems.
• Knowledge of 21 CFR 820 regulations.
• Experience with batch record review and product release activities.
• Experience managing NCRs, CAPAs, deviations, and quality investigations.
• Strong documentation and communication skills.
• Ability to work independently and manage multiple priorities.

• Experience supporting IVD products.
• Knowledge of IVDR requirements.
• Experience in biotechnology, diagnostics, medical device, pharmaceutical, or CDMO environments.
• Experience supporting regulatory inspections and audits.

Job Type & Location

This is a Contract position based out of San Diego, CA.

The pay range for this position is $30.00 - $37.00/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 San Diego,CA.

This position is anticipated to close on Jul 14, 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 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.