• Gxp Quality

    Actalent (Alameda, CA)


    Job Title: Compliance QA Specialist - GxP QualityJob Description

     

    The Compliance QA Specialist will play a crucial role in supporting GxP inspection and audit activities within the inspection readiness program. This includes audit preparation, audit closure, audit observation tracking, and records management. The role involves assisting in the administration and development of standardized templates for inspection readiness and maintaining up-to-date data in the Veeva audit module.

    Responsibilities

    + Maintain audit-related records throughout the program lifecycle.

    + Obtain and compile data relevant to risk assessments.

    + Assist with Inspection Readiness activities across multiple projects in all stages of development or commercialization.

    + Develop and maintain standardized templates based on regulatory requirements.

    + Conduct follow-up activities with internal stakeholders related to the inspection readiness program.

    + Input and maintain inspection-ready information in the eQMS and SharePoint.

    + Support internal and external stakeholders in monitoring supplier performance.

    + Assist in tracking and trending quality metrics related to supplier qualification, audits, and inspection programs.

    Essential Skills

    + Minimum of 3 years experience in biotech, pharmaceutical, or related industry.

    + Excellent attention to detail and strong investigation, problem-solving, and organizational skills.

    + Knowledge and experience with GxP processes related to managing vendors, partners, and suppliers.

    + Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU regulations, ICH guidelines, and other industry standards.

    + Strong written and oral communication skills.

    + Proven organizational skills to obtain data across multi-functional groups and present results clearly.

    Additional Skills & Qualifications

    + BS/B.Sc preferably in the life sciences or STEM disciplines.

    + Administrative experience in organizing and maintaining supplier and audit-related records.

    + Ability to influence decision-makers and utilize sound problem-solving skills to recommend options and implement effective solutions.

    + Highly skilled in working with ambiguity and complexity.

    + Ability to contribute to the development of company objectives and key performance indicators.

    + Strong user of Microsoft Office applications.

    Work Environment

    The role is primarily based in an office setting with standard hours from Monday to Friday, 8 AM to 5 PM. The position involves essential physical requirements such as sitting, standing, and typing, with light physical effort up to 20 pounds.

     

    Job Type & Location

     

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

    Pay and Benefits

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

     

    Application Deadline

     

    This position is anticipated to close on Jan 1, 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.