Pharmacist in Charge (PIC)

Location:

Utah Job Type:

Full-Time Position Summary We are seeking an experienced and highly qualified Pharmacist in Charge (PIC) to lead the safe, compliant, and efficient operation of our 503A Compounding Pharmacy. The PIC is responsible for ensuring all pharmacy operations comply with the Utah Pharmacy Practice Act, Utah Administrative Code, USP <795>, <797>, and <800> standards, and applicable FDA guidance for 503A compounding. This position serves as the primary regulatory contact for the Utah Division of Professional Licensing (DOPL), Utah Board of Pharmacy, and the DEA. The PIC will also work closely with the Designated Representative (DR) overseeing our co-located Class C Wholesale Distribution operation to ensure both licensed entities remain operationally separate and fully compliant. Responsibilities Serve as the designated Pharmacist in Charge (PIC) for the Utah 503A pharmacy license. Supervise all sterile and non-sterile compounding operations in accordance with USP <795>, <797>, and <800>. Develop, implement, and maintain pharmacy Standard Operating Procedures (SOPs). Ensure compliance with all Utah Board of Pharmacy regulations and applicable FDA guidance. Maintain complete and inspection-ready compounding records, prescription documentation, and quality assurance records. Oversee procurement, inventory management, and supplier qualification, including Certificate of Analysis (CoA) review. Manage DEA compliance, including controlled substance inventories, ordering, recordkeeping, and disposal. Lead pharmacy inspections, audits, and regulatory communications. Hire, train, supervise, and evaluate pharmacy technicians and compounding staff. Manage environmental monitoring, cleanroom qualification, and personnel competency programs. Oversee pharmacy quality assurance programs, batch documentation, complaint investigations, and adverse event reporting. Verify prescriptions and provide patient and prescriber consultation as required. Monitor changes to USP standards, FDA guidance, and Utah pharmacy regulations and implement operational updates. Coordinate with the Designated Representative to maintain proper separation between the pharmacy and wholesale distribution operations. 503A Compounding Responsibilities The Pharmacist in Charge will ensure the pharmacy remains fully compliant with

FDA 503A

compounding requirements, including: Monitoring FDA Category 1 and Category 2 Bulk Drug Substance lists. Ensuring all compounded medications are dispensed only pursuant to valid patient-specific prescriptions. Maintaining compliance with FDA guidance regarding peptides and other compounded formulations. Ensuring operations remain within the legal scope of a 503A pharmacy. Required Qualifications Active, unrestricted Utah Pharmacist License (RPh) issued by DOPL (required on the first day of employment). Doctor of Pharmacy (Pharm.

D.) degree from an ACPE-accredited program or equivalent. Minimum of 2-3 years of pharmacist experience with sterile and/or non-sterile compounding. Strong knowledge of USP <795>, USP <797>, and USP <800>. Working knowledge of the Utah Pharmacy Practice Act and Utah Board of Pharmacy regulations. Ability to successfully complete required background screening. Excellent documentation, compliance, and SOP development skills. Ability to serve as the pharmacy's regulatory contact with DOPL, the Utah Board of Pharmacy, and the DEA. Preferred Qualifications Previous experience as a Pharmacist in Charge (PIC) in a 503A compounding pharmacy. Experience with peptide, hormone, or specialty compounding. Familiarity with

FDA 503A

bulk drug substance guidance. Experience with PCAB accreditation or accreditation preparation. Experience working in combined pharmacy and wholesale distribution facilities. Bilingual (English/Spanish) preferred. Experience with cleanroom qualification, environmental monitoring, and USP <800> hazardous drug compliance. Work Environment On-site position; remote work is not permitted under Utah Board of Pharmacy requirements for the PIC designation. Work is performed in cleanroom and controlled environments requiring gowning and aseptic technique. Exposure to hazardous drug handling environments in accordance with USP <800>; PPE and training will be provided. Must be available during pharmacy operating hours, including unannounced inspections by the Utah Board of Pharmacy. Compensation & Benefits Competitive base salary (commensurate with experience) Equity opportunity Benefits package (details to be discussed during the interview process) If you are an experienced compounding pharmacist who is passionate about regulatory excellence, quality, and patient safety, we encourage you to apply!

Benefits:

Health insurance Paid time off

Work Location:

In person

Pay:

$60.00 - $70.00 per hour

Benefits:

Health insurance

Work Location:

In person