Job Description
We are partnered with a global leader of life science equipment manufacturing to hire a seasoned document control specialist to join their newest product release team.
Job Duties:
- Manage the document control process, including creation, revision, approval, distribution, and archiving of controlled documents
- Assign document numbers, ensure timely review and approval of documents and monitor document workflows
- Ensure all documents are accurate, up-to-date, and readily accessible.
- Assist in preparing and maintaining quality records, ensuring completeness, traceability, and accuracy.
- Support internal and external audits by providing controlled documents, quality records, and other required information.
- Collaborate with cross-functional teams to identify document gaps and recommend improvements to meet regulatory standards.
- Manage and monitor employee training records related to controlled documents and QMS processes.
- Facilitate training sessions to educate employees on document control policies and procedures.
- Perform receiving and inspections of incoming materials and equipment to verify conformance with specifications and quality standards.
- Document inspection results and initiate Non-Conformance Material Reports (NCMRs) for any discrepancies.
- Assist with shipping, labeling, and documentation of outgoing product for traceability and accuracy
- Participate in other quality activities as time allows, including non-product software validation, CAPAs, supplier control, equipment IQ/OQ, registration, and calibration activities
- Professionally interacts and maintains effective and open communication with all personnel, vendors, manufacturers, and customers.
- Adheres to all applicable department, production, and company related Operational, Safety and Human Resources policies and procedures.
Requirements:
- Proficiency in Microsoft Office (Word, Excel, Outlook).
- Familiarity with document control software (e.g., SharePoint, Documentum, Aconex, or other electronic document management systems).
- Basic knowledge of databases and file management.
- Understanding of ISO 13485.
- Problem-solving skills to handle document discrepancies.
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