Quality Records Coordinator
4 weeks ago
The Quality Records Coordinator is responsible for reviewing and auditing Manufacturing and Quality Control (QC) related records associated with the release of finished goods, primarily product Device History Records (DHRs). The Quality Records Coordinator oversees the archives of DHRs, Device Master Records (DMRs) and other quality records, ensuring accuracy, legibility, traceability, and retrieval of such records.
Key Responsibilities- Review DHRs for assigned products and approve product release through the Enterprise Resource Planning system (ERP) as necessary.
- Meet unscheduled in workload as necessary to ensure timely release of product.
- Facilitate resolutions for discrepancies in DHR quality records and work with document preparers to resolve questions, inconsistencies, or missing data issues.
- Remain current with all specifications and requirements on which quality records are based and up to date with current Good Manufacturing Processes (cGMP) and manufacturing material/product process flow.
- Provide data and metrics related to accuracy, completeness, and cycle times for records being reviewed and identify areas in need of improvement.
- Ensure priority to urgent matters, identify issues, and work to implement corrective action.
- Participate in regulatory audits as needed and work on assigned special projects.
- High school diploma or equivalent experience preferred; Bachelors degree (Life Sciences) a plus.
- Three (3) to five (5) years previous related Quality Records/Quality Assurance experience; previous experience within a regulated medical device manufacturing or pharmaceutical environment preferred.
- Knowledge of cGMP, GDP, FDA, and ISO preferred.
- Working knowledge of Microsoft Office and experience with large enterprise resource planning (ERP) system and accounting software packages preferred.
- Previous regulatory audit experience a plus.
- Technical writing background/experience a plus.
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
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