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QA Associate Specialist - Document Control

QA Associate Specialist - Document Control

TSR ConsultingBothell, WA, US
1 hour ago
Job type
  • Full-time
Job description

Job Description

83908

  • Please ONLY local candidates to Bothell WA
  • MUST have pharmaceutical exp
  • 100% Onsite - Work Schedule- Sun- Tues OR Tues - Sat- 8am-5pm!

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring a QA Associate Specialist – Document Control for a 12+ months contracting assignment.

Must have skills :

  • Minimum of 3+ years of relevant document control records management experience in a cGMP / FDA regulated environment
  • Experience with an Electronic management system
  • Demonstrated experience with quality management systems
  • Demonstrated knowledge of at least one enterprise computer-related system used for recording of Quality System data (e.g., Content Manager Records Software)
  • Bachelor’s degree or equivalent - Library Science a plus
  • Experience in FDA / EMA regulations in biopharmaceuticals or cell therapy manufacturing is required
  • Experience with Part 11 adherence regarding scanning of records and electronic archiving
  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
  • Strong knowledge of cGMPs and domestic regulatory requirements
  • Knowledge of Records Management, Scanning and organization functions

    • Pay : $42-$44 / hour W2

    Location : Bothell WA

    Responsibilities :

  • Receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records
  • Responsible for the organization of cGXP controlled document files within the Document
  • Center and ensure that records are readily retrievable and sent off to final archive facility as needed
  • Assist with Document Center Archive room activities
  • Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests
  • Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site
  • Support internal and external audits and regulatory inspections
  • Assist with document retrieval / organization support during regulatory inspections
  • Assist with Insurance and Reconciliation of Controlled Forms and Logbooks
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    Document Control Specialist • Bothell, WA, US

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