Document Control Manager
POSITION DESCRIPTION Title: Manager (Mgr.), Quality Assurance Document Control
The Manager, Quality Assurance Document Control (QADC), is a core member of the QA Department. The QADC Manager is responsible for the design, development, implementation and maintenance of the GxP QMS processes. This includes, but is not limited to, Document Control, Change Control, Deviation and other Non-conformances, CAPA, Equipment/Instrument associated systems, and Supplier Management.
- Support the development, and implementation of Quality Systems
- Performs QA document control function, including document login, tracking, processing, approval, distributing, and archiving and has overall responsibility for document control processes.
- Help implement Change Control, Supplier Management and CAPA processes
- Support with the development and review of Operating Procedures (SOPs) required for supporting system change/enhancement to ensure compliance with Good Manufacturing Practices (GMPs) requirements
- Works with functional area managers on the onboarding process for new employees in establishing employee training matrix to ensure compliance with relevant GXP and Corporate policies and procedures.
- Maintains in house training programs including training matrix, training files, and audits of training files.
- Assist in the generation and review of documents used in Manufacturing and Quality Control Testing for accuracy and completeness
- Prepares documentation for filing and maintains original documents and computerized files to support all documentation systems
- Work closely with functional areas for daily management of routing, revisions, approval, and filing of documents.
- Organizes and ensures accurate and reliable filing systems for all electronic and paper-based GXP documents.
- Provides QA support for batch record review as needed.
- All other duties that may be required to fulfill the functions of the position
- Bachelor’s degree in life science or related discipline.
- Extensive knowledge of US and international Quality requirements and the ability to apply operationally to Company projects.
- Minimum 5 years of related experience in FDA regulated industry, preferably biologics, including cellular and/or gene therapies
- Must have experience in implementing quality systems and writing SOP's
- Experience with managing key Quality Management System processes (e.g., Change Management, Supplier Management, Deviations/CAPA, Management Review)
- Proficient in MS Office Applications and familiarity with Electronic Document Management System (EDMS).