Mfg Documentation Specialist
2 weeks ago
**Responsibilities**:
- Creates and updates product/production-related documentation through Document Information Records (DIR) workflow.
- Reviews product/production-related documents for format, accuracy and compliance with existing procedures, providing feedback on content as appropriate
- Creates Document Information, Engineering records and tracks PLM workflows associated with the release of product/production-related documentation.
- Review and manage product label serial management process to ensure compliance with quality and regulatory requirements.
- Ensure timely issuance, retrieval of product/production related documents for product usage with accurate updating of tracking log.
- Manages obsolete PLM documents ensuring outdated or unnecessary documents are properly archived in accordance with records retention schedule and standards.
- Initiate, track till closure on Plant Operations-related documents/records for DocuSign process.
- Coordinate with 3rd party secure records management service partner and internal stakeholder(s) on records storage and retrieval process.
- Maintain up to date employee training status in LMS. Participate in Internal Quality or In-process audit as required
Qualifications:
- Bachelor’s degree or equivalent relevant experience
- Minimum 3 years related experience in a manufacturing environment, GMP/ISO regulated environment preferred.
- Good knowledge with experience in ISO13485 with preferably Good Documentation Practices (GDP).
- Experience working with ERP systems, SAP preferred.
- Strong problem solving, organization, multitasking skills, required.
- Able to prioritize request and changing priorities effectively.
- Meticulous and detailed in record maintenance.
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