• QA Associate Specialist - Document Control

    Actalent (Bothell, WA)


    Quality Assurance – Records Management Specialist

     

    Schedule: Sunday – Thursday

    Position Summary

    The Quality Assurance – Records Management Specialist supports cGMP Document Control operations. This role focuses on receiving, reconciling, scanning, archiving, and retaining GMP records to ensure compliance with regulatory standards.

    Key Responsibilities

    + Organize cGXP controlled document files within the Document Center; ensure records are retrievable and archived as needed.

    + Assist with Document Center Archive room activities.

    + Execute processes for identifying, collecting, distributing, and filing controlled documents.

    + Follow SOPs and work instructions for document approval, effective dates, training workflows, and archiving.

    + Support internal/external audits and regulatory inspections, including document retrieval and auditor escorting.

    + Manage insurance and reconciliation of controlled forms and logbooks.

    Qualifications

    + Education:

    + Bachelor’s degree preferred (Library Science a plus).

    + High school diploma/associate degree with equivalent experience considered.

    + Experience:

    + Minimum 3 years in document control/records management within a cGMP/FDA-regulated environment.

    + Familiarity with FDA/EMA regulations in biopharmaceutical or cell therapy manufacturing.

    + Skills:

    + Strong knowledge of cGMPs and domestic regulatory requirements.

    + Experience with Part 11 compliance for scanning and electronic archiving.

    + Proficiency in MS Office (Word, Excel, Visio, Adobe) and Quality Systems (Document Management System, Quality Management System).

    + Ability to prioritize, multitask, and troubleshoot in a fast-paced environment.

    + Excellent communication and customer service skills.

     

    Job Type & Location

     

    This is a Contract position based out of Bothell, WA.

    Pay and Benefits

    The pay range for this position is $36.02 - $43.95/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 Bothell,WA.

     

    Application Deadline

     

    This position is anticipated to close on Dec 5, 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.