QA Document Control Specialist II (GMP)

The QA Document Control Specialist II (GMP) supports the cGMP Document Control and Records Management functions for the BMS Bothell site. This role is responsible for receiving, reconciling, organizing, scanning, archiving, and retaining GMP records to ensure compliance with regulatory requirements. The specialist maintains controlled document files, supports audits and inspections, and follows established procedures to manage the full lifecycle of GMP documentation. This position requires strong communication skills, attention to detail, and the ability to work independently in a fast-paced, highly regulated environment.

Key responsibilities include daily oversight of the Document Center, execution of site procedures for controlled documents, supporting the document approval and training workflows, facilitating document retrieval during audits and regulatory inspections, and ensuring accurate reconciliation of controlled forms and logbooks. The role also collaborates cross-functionally to meet time-sensitive deliverables and maintain a state of inspection readiness.

Requirements

• Bachelor's degree required; Library Science a plus. A high school diploma or associate degree with equivalent relevant experience may be considered
• Minimum of 3 years of document control and records management experience in a cGMP/FDA-regulated biopharmaceutical or cell therapy environment
• Strong understanding of cGMPs, domestic regulatory requirements, and compliance expectations
• Experience with Part 11 adherence for scanning and electronic archiving
• Proficiency with MS Office tools (Word, Excel, Visio, Adobe) and Quality/Document Management Systems
• Demonstrated experience with enterprise systems for recording Quality System data (e.g., Content Manager Records Software)
• Strong organizational skills and the ability to maintain structured document filing systems and archive workflows
• Ability to prioritize, multitask, meet deadlines, and problem-solve in a fast-paced environment with time-sensitive deliverables
• Excellent communication and customer service skills; ability to work collaboratively across departments
• Innovative, proactive, resourceful, and committed to quality and continuous improvement
• Ability to work independently, escalate issues when required, and build strong internal networks
• Ability to support internal and external audits, including document retrieval, data gathering, and escorting auditors
• Ability to perform occasional manual tasks (moving files, operating office equipment)
  
  

Benefits

Competitive hourly rate: $36.02 - $43.95/hr (W-2 only, no C2C)

Working Hours: Regular business hours. Tuesday - Saturday or Sunday - Thursday (should be flexible to work either)

12-month contract with possible extension

Health Insurance, Holiday Pay, 401(k) Program, And Other Benefits

Employee referral bonus program