QA Associate Specialist Document Control (Bothell)TSR Consulting • Bothell, WA, United States
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QA Associate Specialist Document Control (Bothell)
TSR Consulting • Bothell, WA, United States
2 days ago
Job type
- Full-time
Job descriptionMinimum 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) Bachelors 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 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
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 :
Pay : $42-$44 / hour W2
Location : Bothell WA
Responsibilities :
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Document Control Specialist • Bothell, WA, United States
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