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

Job Tags

Local area,

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QA Associate Specialist - Document Control Job at TSR Consulting, Bothell, WA

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