QA Associate Specialist - Document Control

Actalent•Bothell, WA

29d•$36 - $44•Onsite

About The Position

The Quality Assurance - Records Management Specialist supports cGMP Document Control operations. This role focuses on receiving, reconciling, scanning, archiving, and retaining GMP records to ensure compliance with regulatory standards.

Requirements

Minimum 3 years in document control/records management within a cGMP/FDA-regulated environment.
Familiarity with FDA/EMA regulations in biopharmaceutical or cell therapy manufacturing.
Strong knowledge of cGMPs and domestic regulatory requirements.
Experience with Part 11 compliance for scanning and electronic archiving.
Proficiency in MS Office (Word, Excel, Visio, Adobe) and Quality Systems (Document Management System, Quality Management System).
Ability to prioritize, multitask, and troubleshoot in a fast-paced environment.
Excellent communication and customer service skills.

Nice To Haves

Bachelor's degree preferred (Library Science a plus).
High school diploma/associate degree with equivalent experience considered.

Responsibilities

Organize cGXP controlled document files within the Document Center; ensure records are retrievable and archived as needed.
Assist with Document Center Archive room activities.
Execute processes for identifying, collecting, distributing, and filing controlled documents.
Follow SOPs and work instructions for document approval, effective dates, training workflows, and archiving.
Support internal/external audits and regulatory inspections, including document retrieval and auditor escorting.
Manage insurance and reconciliation of controlled forms and logbooks.