POSITION OVERVIEW

The Quality Specialist is responsible for executing quality-related tasks to support compliance with internal procedures and applicable regulatory standards. When quality-related work is not required, this position will support the pharmacy operations team by performing Pharmacy Technician duties as assigned by the Department Supervisor.

PHYSICAL REQUIREMENTS

Additional Requirements:

• Must be able to lift, stand, kneel, and wear PPE for extended periods
• This is a 100% on-site position. Reliable transportation and punctuality are required.

Key Responsibilities:

• Submit product samples to third-party laboratories, review and document results.
• Compile monthly reports (e.g., environmental monitoring, calibration logs, OIG exclusion checks)
• Perform in-process inspections and quality checks of compounded medications
• Initiate and follow through on quality-related investigations, deviations, and CAPAs
• Assist the PIC with evaluating complaints related to the quality of compounded medication
• Support technician training for non-sterile compounding
• Performs routine facility walkthroughs to ensure compliance with facility SOPs and regulations
• Participate in regulatory inspections (Board of Pharmacy, NABP, FDA, DEA) and work closely with the PIC and compliance for post inspection responses
• Collaborate with corporate Quality on SOP development and implementation
• Maintain equipment list and schedule calibration and facility certifications as required
• Attends and actively participates in all quality department meetings.
• Sets an example by always following assigned SOPs
• Perform Pharmacy Technician duties during non-quality hours as assigned by the Department Supervisor