QA Associate Specialist

Job Description

Job Summary:

• The Quality Assurance – Records Management supports the cGMP Document Control operations for Client Bothell site records management.
• Responsibilities include but are not limited to receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records.

Duties/Responsibilities:

• Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
• Assist with Document Center Archive room activities.
• 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, and archive documents and document change requests.
• Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.
• Support internal and external audits and regulatory inspections.
• This 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.

Education & Related Work Experience Requirements:

• Bachelor’s degree or equivalent. Library Science a plus. High school diploma/ associate’s degree with equivalent combination of education and work experience may be considered.
• Minimum of 3+ years of relevant document control records management experience in a cGMP/FDA regulated environment.
• Experience with Part 11 adherence regarding scanning of records and electronic archiving.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing are required.
• Demonstrated experience with quality management systems.

Knowledge, Skills and Abilities:

• Strong communication and customer service skills.
• Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
• Strong knowledge of cGMPs and domestic regulatory requirements.
• Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.
• Demonstrated knowledge of at least one enterprise computer-related system used for recording of Quality System data (e.g., Content Manager Records Software).

Working Conditions:

• Normal Office working conditions.
• Duties are largely cognitive, but the job may occasionally require minimal motor skills for activities such as moving objects, operating a computer and/or most other office equipment, keyboarding and/or word processing.