What are the responsibilities and job description for the Senior Document Control Coordinator position at BioTalent?
Join a leading global manufacturer in the life sciences sector as a Senior Document Control Coordinator. We are looking for an experienced professional to play a key role in our newest product release team.
Key Responsibilities :
- Oversee the document control process, including the creation, revision, approval, distribution, and archiving of controlled documents.
- Assign document numbers, ensure timely review and approval, and monitor document workflows.
- Maintain accuracy, timeliness, and accessibility of all documents.
- Assist with preparing and maintaining quality records, ensuring they are complete, traceable, and accurate.
- Support audits by providing necessary controlled documents and quality records.
- Collaborate with cross-functional teams to identify gaps and recommend improvements to meet regulatory standards.
- Manage employee training records related to controlled documents and QMS processes.
- Facilitate training sessions on document control policies and procedures.
- Inspect incoming materials and equipment for compliance with specifications and quality standards.
- Document inspection results and initiate Non-Conformance Material Reports (NCMRs) when discrepancies occur.
- Assist with outgoing product shipping, labeling, and documentation to ensure traceability and accuracy.
- Participate in additional quality-related activities as time permits, such as non-product software validation, CAPAs, supplier control, and equipment calibration activities.
- Maintain professional communication with all personnel, vendors, manufacturers, and customers.
- Adhere to operational, safety, and human resources policies and procedures at all times.
Qualifications :
