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 Position Summary 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. Duties and Responsibilities 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. Qualifications 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). Education and Related Work Experience 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. Working Conditions (US Only) 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. Compensation The hourly rate for this position is between $40.00 – $44.00 per hour . Benefits ACA‑compliant medical, dental, and vision insurance for all employees. Sick time benefits as required per state regulations. #J-18808-Ljbffr Sunrise Systems