Specialist, Quality Operations
The Quality Specialist will add and update drugs into the system, create new and revised labels for all segments of Safecor Health's businesses, participate in the in-process or final quality review of specific service segments and supporting processes, participate in control substances inventory management and documentation, and participate in quality assurance activities including facilitation of audits, deviations, incident reports and training. Supports quality in standard processes to ensure compliance with standards; works with operation staff to ensure inspection procedures are implemented and maintained; assists in the development of standards to meet quality specifications: quality oversight during production.
RESPONSIBILITIES
- Enter and track Training Records in the Quality Learning Management System.
- Maintain Supplier Lists
- Create and manage labels for all Safecor Health business segments.
- Facilitate end of day processes for documentation filing and QAD updates.
- Track and document control substance samples and DEA 222 forms management.
- Manage ARCOS quarterly report.
- Participate in the investigation and writing of unplanned deviations and incidents with Operations.
- Responsible for assigned Quality Audit execution, data assembly and report writing.
- Participate in performing segments of incoming inspections for repackaging components or drugs.
- Responsible for final quality check of delineated repackaging formats.
- Responsible for timely and concise communication with customers.
- Perform In-process quality checks and final inspection on commercial lots.
- Complete daily and monthly control retain sample audit.
- Help facilitate quarterly, end of year, and ad hoc basis destruction of Rx and OTC drugs.
- Contact drug manufacturers to obtain drug related information.
- Inspect finished products, supplies, equipment, personnel, and facilities for adherence to quality specifications, current Good Manufacturing Practices.
- Communicate effectively and thoroughly to management and peers any results or inspection findings outside of specifications.