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)
• 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

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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