Document Control Sr Coordinator

About the role

At Zimmer Biomet, you will lead day-to-day document control and records management activities, serve as a senior resource for change control and document lifecycle questions, and ensure controlled information is accurate, current, traceable, and maintained in accordance with Zimmer Biomet procedures and applicable quality-system requirements.

Responsibilities

• Review production batch records for accuracy, completeness, and cGMP compliance.
• Prepare Certificates of Conformance (CoC) for product release.
• Maintain controlled documents and records in compliance with quality system requirements.
• Ensure records are complete, traceable, accurate, and audit-ready.
• Manage document publication, revision control, retention, and archival activities.
• Coordinate document change orders from initiation through approval, implementation, and closure.
• Review change requests for completeness, rationale, impact assessments, and supporting documentation.
• Coordinate cross-functional reviews and approvals.
• Monitor change implementation activities, due dates, and closure requirements.
• Ensure changes are properly documented and compliant with internal procedures.
• Coordinate training activities associated with approved document changes.
• Track training completion and follow up on overdue assignments.
• Provide guidance and support on document control and change control processes.
• Train and coach employees on QMS and documentation best practices.
• Ensure compliance with cGMP, GLP, ISO standards, and internal quality procedures.
• Support quality system effectiveness through proper documentation practices.
• Compile and analyze QMS metrics and quality indicators.
• Identify process improvement opportunities and support approved improvements.
• Support internal, external, and third-party audits.
• Retrieve documentation and provide evidence for audit requests.
• Assist with audit readiness activities and document traceability reviews.
• Support the resolution of documentation-related audit findings.

Requirements

• Experience in Document Control, Records Management, Change Control, Quality