PIC - Sterile Compounding (Nashville, TN)

UNITAS provides clinical staffing and consulting solutions, including contract staff augmentation, permanent talent recruiting, consulting, and clinical coaching. Our extensive experience includes Pharmacy Benefit Management, Long-Term Care, Retail Pharmacy, Hospital, and Leadership, enabling us to connect the best clinical talent with outstanding companies. We know clinicians because we are clinicians!

About the role

The Pharmacist-in-Charge (PIC) provides overall professional, clinical, operational, and regulatory oversight of a state-licensed 503A compounding pharmacy specializing in sterile preparations. Reporting to the pharmacy owners, the PIC ensures that all pharmacy activities comply with applicable federal and state laws, Board of Pharmacy regulations, United States Pharmacopeia (USP) standards, and established pharmacy policies and procedures. The PIC leads sterile compounding operations, personnel competency, quality assurance, environmental monitoring, documentation, medication safety, and continuous quality improvement—maintaining a culture of safety, compliance, accuracy, and operational excellence while ensuring that compounded preparations meet established standards for quality, strength, purity, and intended use.

Responsibilities

Regulatory Compliance & Pharmacy Oversight

• Serve as the Pharmacist-in-Charge and fulfill all associated responsibilities under applicable state law and Board of Pharmacy regulations
• Maintain compliance with Section 503A of the Federal Food, Drug, and Cosmetic Act, relevant FDA requirements, and applicable state and federal pharmacy laws
• Ensure compliance with applicable USP standards, including USP (sterile preparations), where applicable, and for hazardous drugs
• Maintain current pharmacy licenses, permits, registrations, policies, procedures, and required records
• Oversee pharmacy inspections, regulatory inquiries, and corrective action plans, and respond to regulatory findings
• Maintain policies and procedures for prescription intake, compounding authorization, dispensing, labeling, storage, distribution, recalls, and record retention, and ensure activities meet 503A patient-specific requirements
• Monitor regulatory changes and implement appropriate updates to pharmacy practices and procedures

Sterile Compounding Operations

• Oversee daily sterile compounding operations for compliance with approved formulations, master formulation and compounding records, and established procedures
• Ensure appropriate controls for personnel garbing, hand hygiene, aseptic technique, cleaning, disinfection, and material transfer
• Oversee environmental monitoring programs, including viable and nonviable air sampling and surface sampling
• Ensure qualification, certification, and maintenance of cleanrooms, primary engineering controls, and other critical equipment
• Establish and maintain procedures for beyond-use dating (BUD), storage, transport, and handling of compounded sterile preparations
• Ensure appropriate ingredient sourcing, supplier qualification, component inspection, and verification of ingredient identity and quality
• Review and approve compounding procedures, formulations, and documentation, and ensure preparations are compounded, inspected, labeled, and released only by trained, authorized personnel
• Investigate deviations, contamination events, and sterility concerns, and implement corrective and preventive actions

Quality Assurance & Quality Control

• Develop, implement, and maintain a comprehensive quality assurance program for sterile compounding operations
• Establish procedures for quality control, documentation review, product release, and investigation of discrepancies
• Ensure appropriate testing (e.g., sterility, bacterial endotoxins, potency) when required by applicable standards, product characteristics, or procedures
• Review environmental monitoring results, equipment performance, personnel competency records, and quality indicators; identify trends and assess risks
• Maintain procedures for complaints, adverse events, product defects, recalls, and potential patient safety concerns, and implement corrective and preventive actions (CAPA)
• Ensure complete, accurate, and retrievable records, and lead continuous improvement initiatives to reduce errors and strengthen patient safety

Personnel Management & Training

• Supervise and provide professional direction to pharmacists, pharmacy technicians, and other personnel involved in pharmacy operations
• Establish training, qualification, and competency assessment programs for sterile compounding personnel
• Ensure initial and ongoing competency assessments are completed at required intervals and documented appropriately
• Verify that personnel meet applicable licensing, registration, training, and qualification requirements
• Oversee competency in aseptic technique, garbing, cleaning, disinfection, and hazardous drug handling where applicable
• Promote accountability, professionalism, and teamwork, and address performance concerns and noncompliance in a timely, documented manner

Clinical & Medication Safety