We are looking for a Product Release Administrator I to join our team.
The Product Release Administrator I will support Quality Assurance activities related to Device History Records (DHR)/Batch Records and QA Release. Candidates must understand the theories behind Device History Records and reference the applicable regulations and standards as well as conveying an understanding of Scantibodies’ Quality Systems. To have a good understanding of processes related to QA review / release of device history records and specifications. To understand the importance of GMP and Quality Assurance pertaining to product quality and to cite examples of how the failure to comply with these systems could adversely affect the final product and product distribution.
- Responsible as part of Quality Assurance team for the timely review of DHRs and sign off on the final product release for manufacturing departments.
- Confirm that all necessary information/documentation is present, accurate, within Customer and in-house specifications.
- Request additional information from Manufacturing and/or other SLI facilities if needed for the DHR release.
- Ensure the DHR adheres to cGMP and Quality Standards for the building, assembly, packaging, labeling, sample shipping, and ultimately shipment of the final lot.
- Create the associated Production paperwork, i.e. Data Sheets (for all products) and Viral Testing Certification for Human Serum derived products, and other occasional special request certificates when needed.
- Take the responsibility for the integrity of product release information being maintained and updated securely on the Network Server.
- Work with Customer Service, Production Coordination, Manufacturing and Distribution to meet the on-time product shipments.
- Work with Manufacturing to generate Safety Data Sheets (SDS) when needed.
- Assist in training production personnel on GMP practices.
- Assist with GMP metrics and GMP meetings.
- Assist with Labeling review as needed.
- Candidates must have minimum of one (1) year experience in a medical device or pharmaceutical environment.
- Candidates must be familiar with QSR (cGMP) ISO 13485 standards.
We offer a comprehensive benefits package to include paid sick, vacation, medical, dental, vision, life insurance and 401(k).
Email your resume to: firstname.lastname@example.org
Scantibodies Laboratory, Inc. is located at:
10946 Woodside Avenue North, Santee, CA 92071