Role and Responsibilities

This position reports to the Pharmacist in Charge and the Chief Quality and Strategy Officer. The Quality Specialist is responsible for many areas, including but not limited to the following:

• Incoming materials receipt: Review C of A documents for quality control and vendor compliance
• Sample submission to third party labs: potency testing of finished goods. Enter results into document management system
• Proficient in PK software: Compounding record and log review
• Perform in process inspection and quality checks of compounded preparations
• Assist PIC with investigating complaints related to the quality of compounded prescriptions
• Initiate and follow through on quality related tasks including deviations, investigations, and CAPA
• Assist Compounding Pharmacist Manager with non-sterile compounding technician training program
• Conducts routine quality self-audits on the facility to assure compliance with company and regulatory standards are being met
• Participate in all pharmacy inspections, including but not limited to: Board of Pharmacy, NABP, FDA, and DEA
• Collaborate with Corporate Quality department in writing and implementing Standard Operating Procedures (SOPs)
• Attends and actively participates in all quality department meetings
• Sets an example by always following assigned SOPs