Quality Document Control Specialist

Title: QA Associate Specialist- Document Control

Location: Bothell, WA

Duration: 12 months

Shift: Sun- Thurs- Standard Shift

Position 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

Qualifications:

• Strong communication and customer service skills.
• Experience with Part 11 adherence regarding scanning of records and electronic archiving.
• 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
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing are required.
• Demonstrated experience with quality management systems.
• Demonstrated knowledge of at least one enterprise computer-related system used for recording of Quality System data (e.g., Content Manager Records Software)

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.