Quality Assurance Specialist (Part-time)

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

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

PTO, Vacation or Sick Leave

Short and long-term disability

Life Insurance

Job summary

Actalent is seeking a detail-oriented Quality Assurance Specialist for a part-time onsite role in San Diego, CA. You will oversee quality systems, review documentation, and support regulatory compliance in an ISO-regulated IVD manufacturing environment.

The ideal candidate holds a Bachelor's degree in Life Sciences, Engineering, or related field with at least 3 years in QA within regulated manufacturing, and strong knowledge of 21 CFR Part 820.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Business, or related field.
• At least 3 years of QA experience in a regulated manufacturing environment.
• Knowledge of 21 CFR Part 820 and quality management systems.
• Experience reviewing controlled documentation and manufacturing records.
• Strong problem solving and communication skills.

Responsibilities

• Review and approve quality system documents (NCRs, CAPAs, complaints, deviations, change controls).
• Review manufacturing batch records and calibration records for accuracy and compliance.
• Support product and lot release activities, including COAs.
• Participate in investigations, root cause analyses, risk assessments, and effectiveness checks.
• Assist with internal and external audits and regulatory inspections.
• Promote compliance with quality standards and company procedures.

Skills

Quality Assurance

Regulatory knowledge

Documentation review

Analytical thinking

Stakeholder communication

Education

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

Tools

Electronic quality systems

Databases

Reporting tools

Job description

Quality Assurance Specialist (Part-Time)

Location: San Diego, CA (Onsite)

Schedule: Part-Time, 20-30 hours per week, flexible hours

About the Opportunity

We are seeking a detail-oriented Quality Assurance Specialist to join our growing Contract Development and Manufacturing Organization (CDMO) supporting the genomics, molecular diagnostics, and biotechnology industries. This position plays a critical role in ensuring product quality, regulatory compliance, and successful product release within an ISO-regulated in vitro diagnostics (IVD) manufacturing environment.

As a key member of the Quality team, you will provide hands‑on oversight of manufacturing operations, review production and quality documentation, support quality system activities, and collaborate cross‑functionally with Operations, Manufacturing, and leadership teams.

Key Responsibilities

• Review and approve quality system documentation, including:
• Nonconformance Reports (NCRs)
• Corrective and Preventive Actions (CAPAs)
• Complaints
• Deviations
• Change Controls
• Perform detailed review of manufacturing batch records, production documentation, raw material inspection records, and equipment calibration records to ensure accuracy, completeness, and compliance.
• Support product and lot release activities, including preparation and review of Certificates of Analysis (COAs).
• Participate in investigations, root cause analyses, risk assessments, and effectiveness checks.
• Maintain quality records and contribute to document control activities.
• Support internal audits, external audits, and regulatory inspections.
• Assist with quality improvement initiatives and cross‑functional quality projects.
• Promote compliance with applicable quality standards, regulatory requirements, and company procedures.
• Partner with Manufacturing, Operations, and leadership teams to ensure continuous quality and compliance improvements.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Business, or a related discipline.
• Minimum 3 years of Quality Assurance experience in a regulated manufacturing environment.
• Working knowledge of 21 CFR Part 820 and quality management systems.
• Strong experience reviewing controlled documentation and manufacturing records.
• Ability to interpret regulatory requirements and quality standards.
• Excellent problem‑solving, analytical, and decision‑making skills.
• Effective communication skills with both technical and non‑technical stakeholders.
• Proficiency with electronic quality systems, databases, and reporting tools.

Preferred Qualifications

• Experience within the IVD, medical device, biotechnology, life sciences, or CDMO industries.
• Knowledge of IVDR requirements and regulated product development environments.
• Experience supporting ISO‑compliant quality systems and product release activities.

Why Join the team?

• Play a high‑impact role directly supporting product quality and release decisions.
• Gain exposure to cutting‑edge genomics and molecular diagnostics technologies.
• Collaborate with a growing, innovative organization serving leading biotechnology customers.
• Work alongside experienced Quality, Manufacturing, and Operations professionals.
• Contribute to quality initiatives that drive compliance, operational excellence, and business growth.

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.

• 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)

Application Deadline

This position is anticipated to close on Oct 30, 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 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.