Quality Assurance

Job Title: Quality Assurance SpecialistJob Description

The Quality Assurance Specialist will support Quality Assurance activities within a regulated biotechnology manufacturing environment, with a primary focus on investigations related to manufacturing, facilities, equipment, processes, and quality systems.

Responsibilities

• Lead and support quality investigations involving manufacturing processes, facilities, equipment, materials, and quality systems.

• Investigate deviations, nonconformances, process discrepancies, equipment failures, environmental or facility-related events, and other GMP quality events.

• Perform structured root cause analysis using tools such as 5 Whys, Fishbone/Ishikawa analysis, fault tree analysis, or similar methodologies.

• Develop, document, and track Corrective and Preventive Actions (CAPAs) resulting from investigations.

• Determine the potential impact of quality events on product quality, manufacturing processes, equipment, facilities, and GMP compliance.

• Work cross-functionally with Manufacturing, Facilities, Engineering, Operations, and Quality Assurance to gather information and resolve investigations.

• Review manufacturing documentation, equipment records, maintenance records, procedures, work orders, batch records, and other supporting documentation as part of investigations.

• Ensure investigations clearly document what happened, why it happened, the impact of the event, root cause, and actions required to prevent recurrence.

• Review and approve investigation reports for accuracy, completeness, and compliance with internal quality procedures.

• Support CAPA effectiveness checks and ensure corrective actions appropriately address identified root causes.

• Identify recurring quality issues and support trending and continuous improvement activities.

• Assist with updates to Standard Operating Procedures (SOPs), work instructions, and other controlled documentation resulting from investigations.

• Support inspection and audit readiness and provide investigation documentation when required.

• Ensure quality activities comply with applicable GMP requirements, internal Quality Management Systems, and company procedures.

Essential Skills

• Experience in quality assurance within a biotechnology, biopharmaceutical, pharmaceutical, medical device, or other regulated manufacturing environment.

• Hands-on experience conducting or supporting quality investigations, deviations, nonconformances, root cause analysis, and CAPAs.

• Experience working with GMP manufacturing operations and Quality Management Systems.

• Ability to investigate issues involving facilities, manufacturing processes, equipment, and quality systems.

• Strong technical writing and documentation skills.

• Ability to review complex information, identify potential root causes, and develop clear investigation conclusions.

• Strong communication skills and ability to collaborate across Manufacturing, Facilities, Engineering, Operations, and QA.

Additional Skills & Qualifications

• Bachelor's degree in Biology, Biotechnology, Chemistry, Engineering, Life Sciences, or a related technical discipline preferred.

Work Environment

Work primarily occurs in a lab environment.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $30.00 - $40.00/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 Jose, CA.

Application Deadline

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

Workplace Type

This is a fully onsite position in San Jose,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 [email protected] 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.