Quality Specialist
Current• Review job records at specified intervals for accuracy, completeness, and adherence to GMP and QMS guidelines• Ensure product has been received and prepared for processing as described in Receiving and Pre-Processing Product for Irradiation work instruction • Review processing run records for accuracy and verify processed product has been completed per customer requirements or validated specification• Manage the Non-Conformance program through initiation, investigation, completion, and review of non-conformance reports • Manage the CAPA program by collecting and analyzing key data on NCR trends and KPIs, collaborating with management on process improvements and overseeing large process implementation• Receive incoming customer complaints and work with the necessary departments to resolve issues in a timely manner• Initiate and review changes to controlled documents through Change Orders in accordance with document control SOPs and Work Instructions• Organize and conduct training sessions for employees as necessary for onboarding, development, and corrective purposes• Schedule / perform calibrations and preventative maintenance for equipment