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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