QULAITY SUPERVISOR IN A BLOOD PLASMA CENTER

1. Ensure Plasma Center compliance with all applicable state, federal and TPR designated regulations.
2. Ensure that SOP’s are updated and validated and that staff perform according to all SOP’s.
3. Ensure all plasma shipments meet specifications and requirements as defined in the Donor Center Standard Operations Procedures manual.
4. Authorize final shipment release.
5. Ensure accurate labeling and documentation of shipments.
6. Document and track/trend center quality incidents as well as provide follow-up on incidents/errors as required. Report all issues to the Center Manager.
7. Report compliance status to necessary parties.
8. Ensure accuracy of donor files.
9. Ensure that all supplies and materials ordered meet quality regulations.
10. Direct the maintence and calibration of equipment and documentation of procedures.
11. Ensure that CLIA proficiency test surveys, complaint investigations and training have been properly documented.
12. Monitor training documents to ensure compliance with all applicable policies and procedures.
13. Ensure that job and cGMP training is completed, documented and on file.
14. Oversee execution, documentation and review of internal and external audits.
15. Track and follow-up on corrective actions and preventative measures.
16. Ensure that QC checks are performed as required and are in acceptable ranges for test reagents.
17. Provide suggested updates and revisions to standard operating procedures.
18. Update the Center Procedure Manual with the most recent approved procedures and forms.
19. Collaborate with Center Managers to ensure product quality.
20. Implement continuous quality improvement.
21. Periodic audits to ensure employees are following all processes and procedures and are in compliance with all SOP’s and regulations.
22. Prepare quality analysis reports to track issues and set goals.

salary range $44K - $59K

Position Requirements Bachelor's Degree required. One (1) year experience in a donor center or similar Quality Assurance or medical field experience or equivalent combination or education, training, and experience. Organizational and communication skills required. Must have legible handwriting. Must be able to use a PC. Mathematics knowledge is a requirement. Must be able to work independently and multi-task effectively. Ability to understand and assess FDA regulations. Individual should pursue ASQ certification during employment.

General requirements :
Organizational and communication skills required. Must have legible handwriting. Must be able to use a PC. Mathematics knowledge is a requirement. Must be able to work independently and multi-task effectively. Ability to understand and assess FDA regulations. Individual should pursue ASQ certification during employment