Quality Assurance Specialist
15 hours ago
Celularity is a biotechnology company leading the next evolution in cellular medicine. We are seeking a highly skilled Quality Assurance Specialist to join our team.
The Quality Assurance Specialist will be responsible for reviewing all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and make determinations of acceptability for product release. The successful candidate will work with other departments to ensure the quality of products, review change controls, and support investigations of quality issues.
Responsibilities- Conduct QA review of various product-related records for completeness and accuracy.
- Conduct QA review of biobanking files for completeness and accuracy.
- Conduct QA oversight of documentation necessary for transplantation of materials.
- Ensure review and quality decision of all batch related documentation and perform the batch disposition.
- Conduct issuance of Batch records and labels.
- Follow-up to verify completion of quality event activities.
- Support incoming materials inspections and release.
- Communicate and resolve errors or discrepancies with related personnel.
- Conduct QA verification and reconciliation of product packaging and labeling.
- Conduct QA review and approval of various calibration, validation and environmental monitoring documents for accuracy and trends.
- Provide input/suggestions for revising and improving processes and procedures.
- Handle product related quality events such as change controls and investigations.
- Coordinate activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations.
- Bachelor's degree in a scientific discipline required.
- Minimum of 2 years of quality assurance experience.
- Detail oriented with high degree of focus.
- Able to follow instructions and procedures, both written and verbal.
- Able to perform with minimal supervision and contribute to a team environment.
- Able to communicate results and issues effectively, both written and orally.
- Able to exercise judgment within defined procedures.
- Working knowledge and ability in using Microsoft Office.
- Knowledge/experience with electronic quality systems and enterprise resource planning systems preferred.
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