• Senior Quality Assurance Specialist

    Actalent (Irvine, CA)


    Job Title: Sr. Quality Assurance Specialist

    Job Description

    We are seeking two experienced Sr. Quality Assurance Specialists to join our QA team. The ideal candidates will play a crucial role in ensuring the quality and compliance of our pharmaceutical products.

    Responsibilities

    + Review paper batch records for completeness and accuracy, and resolve any discrepancies identified.

    + Enter and verify data from batch records into product sheets and maintain the system.

    + Participate in deviation investigations and implement corrective and preventive actions (CAPA).

    + Assist in writing and revising Standard Operating Procedures (SOPs) to ensure compliance with current Good Manufacturing Practices (cGMP).

    + Assist with certificates of conformance and prepare executed batch records for product release.

    + Prepare in-process samples for Quality Control.

    Essential Skills

    + Minimum of 5 years of experience in batch record review within a pharmaceutical setting.

    + At least 5 years of experience in the pharmaceutical industry.

    + Over 3 years of experience in CAPA investigations.

    + More than 3 years of experience handling deviations.

    + At least 4 years of experience with paper batch records.

    + Familiarity with FDA regulations.

     

    Additional Skills & Qualifications

     

    + Bachelor's degree in a Scientific discipline.

    + 3-5 years of Quality Assurance experience in a pharmaceutical setting.

    + Experience in batch record reviewing and product release.

    Work Environment

    The role is based in an office space shared with the QA Supervisor and QA Technicians. The work environment is collaborative, emphasizing teamwork and attention to detail.

     

    Job Type & Location

     

    This is a Contract to Hire position based out of Irvine, California

    Pay and Benefits

    The pay range for this position is $32.00 - $36.00/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 Oct 24, 2025.

    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.