• Quality Assurance Specialist

    Actalent (Irvine, CA)


    Job Title: Quality Assurance SpecialistJob Description

     

    We are seeking a dedicated Quality Assurance Specialist to ensure compliance with cGMP regulations and standard operating procedures. The role involves coordinating internal training, reviewing GMP records, and supporting audits. You'll work closely with QA management to enhance documentation quality and maintain Quality Systems.

    Responsibilities

    + Comply with cGMP regulations and all standard operating procedures.

    + Assist in ensuring personnel comply with cGMP regulations and provide guidance as needed.

    + Coordinate and organize internal training programs for GMP activities according to SOP.

    + Perform timely review of GMP records, including Batch Records, Laboratory Records, and Notebooks.

    + Collaborate with QA management to address documentation quality proactively.

    + Review and release components, raw materials, and finished products.

    + Create, revise, and review SOPs, protocols, reports, change controls, and other GMP documentation.

    + Conduct and review complaint, non-conformance, and deviation investigations.

    + Support and organize stability studies for finished products.

    + Assist in preparation and during internal, customer, and agency audits.

    + Maintain and improve assigned Quality Systems or processes, tracking and presenting quality metrics (KPIs).

    + Work with QA management to ensure continuous improvement of Quality Systems for regulatory compliance.

    Essential Skills

    + Bachelor’s degree in a scientific discipline or equivalent experience in quality control or quality assurance in manufacturing.

    + 4+ years’ experience in quality control or quality assurance associated with manufacturing.

    + Knowledge and experience with cGMP regulations (21 CFR 210/211).

    + Ability to read and interpret technical procedures, SOPs, GMPs, and governmental regulations.

    Work Environment

    The work environment involves utilizing electronic Quality Management Systems and other software for batch record review, quality assurance, document control, and lab reporting. The role requires ensuring compliance with FDA regulations and maintaining high standards of documentation and product quality.

     

    Job Type & Location

     

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

    Pay and Benefits

    The pay range for this position is $28.00 - $35.00/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)

     

    Workplace Type

     

    This is a fully onsite position in IRVINE,CA.

     

    Application Deadline

     

    This position is anticipated to close on Jan 23, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.