PIC - Sterile Compounding (Nashville, TN)

UNITAS•Nashville, TN

20d•$90 - $90

About The Position

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 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. The role maintains a culture of safety, compliance, accuracy, and operational excellence and ensures compounded preparations meet established standards for quality, strength, purity, and intended use. The position is scheduled Monday through Friday, with specific daily hours to be determined. Estimated compensation is $187,200 per year. The role includes 15 days of PTO to start and paid holidays.

Requirements

Graduate of an accredited School or College of Pharmacy with a Doctor of Pharmacy (Pharm.D.) or other qualifying pharmacy degree.
Current, active pharmacist license in the state where the pharmacy is located, in good standing and without restrictions that would prevent performance of the role.
Meets all applicable state requirements to serve as Pharmacist-in-Charge of a 503A compounding pharmacy.
Demonstrated experience in sterile compounding and knowledge of applicable USP standards and regulatory requirements.
Knowledge of aseptic technique, cleanroom operations, environmental monitoring, personnel competency assessment, quality assurance, and contamination control.
Strong understanding of pharmacy law, medication safety, documentation requirements, and compounding quality systems.
Ability to interpret regulations, develop policies and procedures, investigate deviations, and implement effective corrective actions.
Strong leadership, communication, organizational, and problem-solving skills.
Proficiency with pharmacy management systems, electronic documentation, and standard business software.

Nice To Haves

Two or more years of experience in sterile compounding pharmacy operations or a comparable pharmacy leadership role.
Previous experience serving as a Pharmacist-in-Charge, pharmacy manager, or sterile compounding supervisor.
Experience preparing for and responding to Board of Pharmacy inspections or other regulatory audits.
Experience managing USP compliance programs, environmental monitoring, cleanroom certification, and quality assurance initiatives.
Relevant sterile compounding training, certifications, or documented advanced competency.

Responsibilities

Serve as Pharmacist-in-Charge and fulfill 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, applicable state and federal pharmacy laws, and USP standards including <797>, <795> where applicable, and <800> for hazardous drugs.
Maintain pharmacy licenses, permits, registrations, policies, procedures, and required records; oversee inspections, regulatory inquiries, corrective action plans, and responses to findings.
Maintain procedures for prescription intake, compounding authorization, dispensing, labeling, storage, distribution, recalls, and record retention, ensuring compliance with 503A patient-specific requirements.
Monitor regulatory changes and implement appropriate updates to pharmacy practices and procedures.
Oversee daily sterile compounding operations, including approved formulations, master formulation and compounding records, personnel garbing, hand hygiene, aseptic technique, cleaning, disinfection, and material transfer.
Oversee environmental monitoring, 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, 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; 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.
Develop, implement, and maintain a comprehensive quality assurance program for sterile compounding operations; establish procedures for quality control, documentation review, product release, and discrepancy investigations.
Ensure appropriate sterility, bacterial endotoxin, and potency testing 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 processes for complaints, adverse events, product defects, recalls, and patient safety concerns; implement corrective and preventive actions and continuous improvement initiatives.
Supervise and provide professional direction to pharmacists, pharmacy technicians, and other personnel involved in pharmacy operations.
Establish training, qualification, and competency assessment programs; ensure assessments are completed at required intervals and documented, and verify personnel licensing, registration, training, and qualification requirements.
Oversee personnel competency in aseptic technique, garbing, cleaning, disinfection, and hazardous drug handling where applicable; promote accountability, professionalism, and teamwork and address performance concerns and noncompliance.
Provide pharmacist oversight of prescription review, ingredient selection, formulation appropriateness, calculations, labeling, and final verification.
Assess prescription completeness, patient-specific needs, dosage, route of administration, and potential incompatibility or safety concerns; support communication with prescribers and healthcare professionals.
Establish processes for identifying, documenting, and addressing medication errors, adverse events, and product complaints; protect patient confidentiality and comply with privacy requirements.
Oversee qualification, calibration, maintenance, cleaning, and performance monitoring of compounding and quality assurance equipment.
Ensure cleanrooms, controlled environments, refrigerators, freezers, and storage areas meet established specifications; review temperature monitoring and excursion investigations.
Ensure inventory controls, expiration-date monitoring, storage conditions, and traceability of active pharmaceutical ingredients and components; maintain procedures for receiving, quarantine, release, rejection, and disposal of materials.
Coordinate facility maintenance, certification, and remediation.
Develop, review, approve, and maintain pharmacy policies, standard operating procedures, and training materials; ensure timely, accurate completion of compounding, prescription, personnel, equipment, cleaning, and quality records.
Provide ownership with reports on pharmacy performance, compliance status, quality trends, and operational risks.
Participate in budgeting, staffing, workflow planning, and operational improvement initiatives; communicate with regulatory authorities, healthcare professionals, vendors, and other stakeholders.
Perform other duties as assigned.