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Quality Associate II

Company: Seattle Genetics
Location: Bothell
Posted on: February 20, 2021

Job Description:

Seattle GeneticsSeattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
#LI-KC1 Global Quality ⋅ Bothell, WashingtonDescription

The QA Associate II is responsible for performing day to day activities related to Quality Document Control (QDC) Activities and GMP Records filing systems for both physical and electronic records. QDC will own and manage the GMP Quality business processes supporting Quality Document Control authoring, review, approval, and archive of GMP lifecycle documents,
The QDC responsibilities include following the corporate requirements for the Document Control program, making decisions within the scope of the program, while providing strong customer service and user support by answering questions and providing guidance.

Principal Responsibilities:

  • Execute on defined and established procedures, work instructions and templates
  • Process documents in electronic Document Management System
  • Answer basic questions and send routine notifications
  • Issue and reconcile batch records, forms, and logbooks
  • Maintain and distribute documents to Controlled Document Locations
  • Back-up the Records Management job function as required
  • Responsible for receiving and logging GMP records, cataloging, physical or electronic filing, and retrieval as needed
  • Works with GMP personnel submitting and retrieving records to ensure records are maintained and tracked in a compliant manner and are readily retrievable
  • Participates in cross-functional teams to implement, update, or upgrade systems or processes related to the management of GMP records
  • Supports GMP regulatory audits and inspections ensuring timely retrieval of both physical and electronic records
  • Scans and digitizes GMP records and verifies as true copies.
  • Performed reconciliation of completed records issued for GMP activities
  • Collects and assists with reporting on relevant metrics
  • Works with off-site storage facilities to ensure compliant submission and retrieval of GMP records
  • Contribute to milestones related to specific projects
  • Participates in continual improvement activities within Document Control and GMP Records managementRequired Qualifications:
    • Bachelor's degree in relevant field or equivalent experience; or 2+ years of relevant quality assurance, manufacturing, or quality control experience in the biotech or pharmaceutical industry
    • Knowledge of physical and electronic Document Management workflows and principles
    • Working knowledge of cGMP, including familiarity with ICH guidance, regulatory guidance, and pharmaceutical organization guidance
    • Ability to manage day-to-day workload with minimal oversight
    • Basic knowledge of continuous improvement principles and practices
    • Advanced expertise with Office 365, especially Excel
    • Experience with applicable software (e.g., Learning Management System, electronic Quality Management System, data analytics, etc.)
    • Excellent written and oral communication skills
    • Highly organized and detail oriented
    • Demonstrated problem-solving skills and techniques commensurate with job level
    • Strong team player that can also work independently to achieve objectives
    • Proven ability to work effectively in a fast-paced team environment Preferred Qualifications:
      • Familiarity with cGMP and/or biotechnology industry
      • Working knowledge of current industry practices and standards
      • Prior QDC experienceAs the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit .

        #LI-KC1 PI129046018

Keywords: Seattle Genetics, Seattle , Quality Associate II, Other , Bothell, Washington

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