Quality Control Supervisor
JOB TITLE: QC Supervisor – Incoming Materials Group (1st Shift)
DEPARTMENT: Quality Control
REPORTING TO: Director, Quality Control
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIY
- Ensure that sampling, testing, and documentation of incoming materials is performed in compliance with established, approved written procedures
- Ensure that assignments are given to trained individuals in the group
- Re-assign workload as priorities change
- Provide guidance to resolve any issues which arise in the group
- Monitor material SAP due dates and report any release delays to the QC Director
- Review results in SAP for data entry completeness and generate the C of A.
- Keep Incoming Material C of A files available and secure
- Recognize OOS and atypical results that warrant an investigation and complete the laboratory investigation report along with the QC analyst. Open event notifications to QA (if necessary) within designated time frames
- Review and revise SOP’s, TMs and Specifications as needed.
- Maintain a CGMP compliant laboratory (Equipment, reagents, standards).
- Supervise QC Chemists, Samplers and Technicians: work with QC Director to set group objectives, monitor group performance and conduct individual performance assessments
- Maintain chain of custody for Incoming Test Samples and Incoming Retain Samples.
- Basic Office Setting-Exposure to Computer monitor
- Minimum BS in a scientific discipline, MS preferred
- At least 5 years’ experience in a laboratory environment with a BS.
- Previous Supervisory Skills
- Above average communication , mathematics and computer skills
- Works well in a team environment;
- In-depth knowledge of cGMP’s and USP regulations and specifications.