Document Control Specialist

QA Associate Specialist – Document Control

Location: Bothell, WA

Position Type: Hourly contract position (W2 only)

Pay Rate: $40–$44 per hour on W2

Work Schedule: Sunday – Thursday

The Quality Assurance – Records Management supports the cGMP Document Control operations for BMS Bothell site records management. Responsibilities include receiving and reconciling GMP records, managing scanning, archival, and retention of GMP records.

• Responsible for organizing cGXP controlled document files within the Document Center and ensuring records are readily retrievable and sent to the final archive facility as needed.
• Assist with Document Center Archive room activities.
• Apply knowledge of Records Management, Scanning, and organization functions.
• Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, archive documents, and document change requests.
• Execute process and procedures for identifying, collecting, distributing, and filing controlled documents for the site.
• Support internal and external audits and regulatory inspections, which may require data gathering, interviewing, or escorting auditors during the audit.
• Assist with document retrieval/organization support during regulatory inspections.
• Assist with insurance and reconciliation of controlled forms and logbooks.

• Strong communication and customer service skills.
• Experience with Part 11 adherence regarding scanning of records and electronic archiving.
• Proficient in MS Office (Word, Adobe, Visio, Excel) and Quality Systems (e.g., Document Management System, Quality Management System).
• Demonstrates innovative, proactive, and resourceful behaviors; committed to quality and continuous improvement.
• Ability to prioritize, manage time, multi‑task, and troubleshoot effectively.
• Effective and collaborative work at a fast pace with cross‑functional departments to finalize time‑sensitive deliverables.
• Strong knowledge of cGMPs and domestic regulatory requirements.
• Independent in completing tasks, notifying manager of decisions outside established processes, and building an internal network.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is required.
• Demonstrated experience with quality management systems.
• Experience with at least one enterprise computer‑related system used for recording Quality System data (e.g., Content Manager Records Software).

• Bachelor’s degree or equivalent (Library Science is a plus). High school diploma / associate’s degree with equivalent education and work experience may be considered.
• Minimum of 3+ years of relevant document control records management experience in a cGMP/FDA regulated environment.

• Normal office working conditions.
• Duties are largely cognitive, with occasional minimal motor skills for moving objects, operating a computer, keyboarding, or word processing.
• This job description describes general duties; additional job‑related duties may be assigned by management.

The hourly rate for this position is between $40.00 – $44.00 per hour
.

• ACA‑compliant medical, dental, and vision insurance for all employees.
• Sick time benefits as required per state regulations.