QA Records Management Associate

Job Title: QA Records Management Associate

Location: Bothell, WA – 100% Onsite

Schedule: Sunday–Thursday

Position Summary

We are seeking a Quality Assurance – Records Management Associate to support cGMP Document Control operations at a biopharmaceutical manufacturing site. This role involves receiving, reconciling, scanning, archiving, and managing GMP records while ensuring compliance with regulatory requirements and internal quality standards.

Key Responsibilities

Organize cGXP controlled document files within the Document Center to ensure records are easily retrievable and archived promptly.

Assist with Archive Room operations and overall Document Center activities.

Perform records management tasks including scanning and organizing controlled documentation.

Follow SOPs, policies, and work instructions to support document approval processes, effective date assignments, training workflows, and archival of documents and change requests.

Execute processes for identifying, collecting, distributing, and filing controlled documents across site functions.

Support internal and external audits, including gathering data, facilitating document retrieval, assisting with organization, and escorting auditors during inspections.

Manage and reconcile controlled forms and logbooks.

Provide document retrieval support during regulatory inspections.

Required Qualifications

Strong communication and customer service skills.

Experience with Part 11 compliance related to scanning and electronic archiving.

Strong proficiency with MS Office (Word, Excel, Adobe, Visio) and Quality Systems such as Document Management and Quality Management Systems.

Demonstrated behaviors of innovation, proactivity, resourcefulness, and commitment to quality.

Ability to prioritize tasks, manage time effectively, multitask, and troubleshoot issues.

Ability to collaborate in a fast-paced environment and meet time-sensitive deliverables.

Strong knowledge of cGMPs and domestic regulatory requirements.

Ability to work independently while escalating issues outside of established processes.

Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy environments.

Experience with quality management systems.

Familiarity with enterprise systems used for Quality System data (e.g., Content Manager Records Software).

Education & Experience Requirements

Bachelor’s degree preferred; Library Science is a plus.

High school diploma or Associate’s degree with relevant experience may be considered.

Minimum 3+ years of document control or records management experience in a cGMP/FDA-regulated environment.

Working Conditions

Standard office environment with primarily cognitive responsibilities.

Occasional minimal physical activity such as moving files, operating office equipment, or computer usage.