Coordinator I, Quality Records
WerfenSan Diego, California, United States
Posted February 4, 2024
Full Time
About the Company
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.
Job Description
The Quality Records Coordinator is responsible for reviewing and auditing Manufacturing and Quality Control (QC) related records associated with the release of products in manufacturing, primarily product Device History Records (DHRs).
Requirements
- Review DHRs for assigned products
- Audit DHRs to ensure accuracy, legibility, and traceability
- Continually work to achieve assigned review time goals
- Provide data and metrics related to accuracy, completeness and cycle times for records being reviewed
- Ensure priority to urgent matters
- Provide additional administrative support as directed
- Participate in regulatory audits as needed
- Ensure and maintain compliance with the company’s quality system requirements through training and adherence to policies, procedures, and processes
Benefits
- Health, Dental, Vision, and Life Insurance
- 401(k) and Profit Sharing
- Paid Time Off and Holidays
- Access to Employee Assistance Program (EAP)
- Education Assistance