Quality Assurance Specialist

Actalent; San Diego (CA); On-site; USD 41,000 - 51,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan

Paid time off

Job summary

Actalent in San Diego, CA seeks a Quality Assurance Specialist to provide quality oversight in an ISO-regulated manufacturing environment. The role centers on reviewing batch records and documentation to ensure accuracy, completeness, and compliance prior to product release.

Responsibilities include reviewing production records, material inspection records, calibration docs, supporting lot release, and preparing Certificates of Analysis as needed.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Business, or related field.
• 3+ years of QA experience in regulated manufacturing.
• Preferred knowledge of IVDR.

Responsibilities

• Review and approve quality system records including NCRs, CAPAs, complaints, deviations, and change orders.
• Support investigations, root cause analyses, risk assessments, and effectiveness checks.
• Maintain quality records and support internal and external audits.
• Participate in training activities and assist with various quality projects as business needs arise.
• Help maintain compliance with ISO:2016 standards and support quality system activities within a regulated IVD/CDMO environment.
• Perform detailed review of manufacturing records, production records, material inspections, calibration records, and support product release activities.

Skills

21 CFR 820

Documentation review

Regulatory interpretation

Problem solving

Communication skills

Computer systems

Education

Bachelor's degree in Life Sciences, Engineering, Business, or related field

Job description

Job Title: Quality Assurance SpecialistJob Description

The Quality Assurance Specialist will provide quality oversight for manufacturing operations within an ISO-regulated IVD manufacturing environment. The primary focus of the role is reviewing batch records and manufacturing documentation to ensure accuracy, completeness, and compliance before product release. Daily responsibilities include reviewing production records, raw material inspection records, equipment calibration documentation, supporting lot release activities, and preparing Certificates of Analysis as needed.

Responsibilities

• Review and approve quality system records including NCRs, CAPAs, complaints, deviations, and change orders.

• Support investigations, root cause analyses, risk assessments, and effectiveness checks.

• Maintain quality records and support internal and external audits.

• Participate in training activities and assist with various quality projects as business needs arise.

• Help maintain compliance with ISO:2016 standards and support quality system activities within a regulated IVD/CDMO environment.

• Perform detailed review of manufacturing records, production records, material inspections, calibration records, and support product release activities.

Essential Skills

• Familiarity with 21 CFR 820 regulations.

• Strong documentation review skills.

• Ability to interpret regulatory requirements and quality standards.

• Independent problem-solving and decision‑making capabilities.

• Strong communication skills with both technical and non‑technical stakeholders.

• Proficiency with computer systems and reporting tools.

Additional Skills & Qualifications

• Bachelor's degree in Life Sciences, Engineering, Business, or related field.

• 3+ years of QA experience in regulated manufacturing.

• Preferred knowledge of IVDR.

Work Environment

The position is onsite with a flexible part‑time schedule of 2030 hours per week. This role is situated in a growing San Diego‑based CDMO supporting genomics, molecular diagnostics, and biotechnology companies. The work environment offers the opportunity to collaborate with Operations, Manufacturing, Quality Assurance, and leadership teams, providing a high‑visibility quality role with direct influence on product release and regulatory compliance.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $30.00 - $37.00/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 & Location

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

Application Deadline

This position is anticipated to close on Nov 9, 2026.

Workplace Type

This is a fully onsite position in San Diego,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 [e-mail] 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.