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Compliance Pharmacist, Sterile Compounding

Hims & Hers· PHARMACY
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Mesa, ArizonaFull-timePosted 5d ago

About the role

Compliance Pharmacist with sterile compounding expertise to serve as the PIC Designee for sterile compounding at a 503A pharmacy, ensuring regulatory and quality standards are met and supporting scale of operations.

Responsibilities

  • Act as the Designee for the 503A pharmacy in accordance with applicable regulations and USP for the appropriate functional area.
  • Ensure active state pharmacist licensure in applicable jurisdictions and fulfill backup PIC responsibilities as needed.
  • Act as a member of the CQI Committee, facilitate the CQI process according to the SOP.
  • Ensure ongoing compliance with USP <797> and <800> (as applicable), state board of pharmacy requirements, and internal policies
  • Design, execute and maintain a self-inspection program for sterile compounding to support continuous quality improvements.
  • Implement changes to ensure compliance and complete Board of Pharmacy compliance checklists as applicable.
  • Support the PIC in maintaining pharmacy licensure, registrations, and regulatory readiness and recordkeeping
  • Oversee compliance aspects of sterile compounding operations, including aseptic technique, environmental controls, cleaning, and disinfection in partnership with Quality.
  • Assist in the review and approval of sterile compounding SOPs, documentation, and records to ensure regulatory alignment
  • Monitor regulatory changes and assess operational impact; partner with stakeholders to implement updates
  • Support environmental monitoring, personnel qualification, media fills, and competency programs in partnership with training and quality departments.
  • Participate in investigations, root cause analyses, and CAPA development related to deviations or quality events
  • Prepare for and support state board inspections, internal audits, and third-party assessments
  • Ensure training programs and competencies are in line with regulatory standards and appropriately documented
  • Track and ensure timely resolution of inspection findings and audit observations
  • Partner cross-functionally with pharmacy operations, quality, and leadership to proactively manage compliance risks
  • Escalate significant compliance issues and trends to the PIC as appropriate

Qualifications

  • 5 years of Sterile compounding experience
  • Pharmacy degree from an ACPE-accredited school of pharmacy
  • Board Certified Sterile Compounding Pharmacist (BCSCP) certification
  • Active, unrestricted Pharmacist license in the state of practice
  • Eligibility and willingness to obtain reciprocal licenses in other states
  • Experience in sterile compounding, pharmacy compliance, or quality roles
  • Strong working knowledge of USP <797>, <800>, and state board of pharmacy regulations applicable to 503A pharmacies
  • Experience supporting audits, inspections, or regulatory inquiries
  • Excellent attention to detail with strong documentation and organizational skills
  • Ability to translate regulatory requirements into practical, scalable processes
  • Willingness to travel

Skills

Required:Sterile compoundingRegulatory complianceDocumentation and recordkeepingAudits and inspections
Nice to have:CAPA and root cause analysis

Benefits

  • Not specified in the provided description
Last updated Oct 21, 2026. Interested? Apply on the company site.

About Hims & Hers

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