Compliance Pharmacist, Sterile Compounding
Hims & Hers· PHARMACY
New Albany, OhioFull-timePosted 5d ago
About the role
Compliance-focused pharmacist role ensuring regulatory adherence and quality in a 503A sterile compounding pharmacy; primary expert on applicable state and federal regulations with a strong emphasis on USP <797> and <800> compliance, audits, and continuous quality improvement.
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 complianceAudits and inspectionsQuality systems (CQI/CAPA)
Benefits
- Comprehensive Total Rewards package that may include an equity grant
- Competitive compensation aligned with location and experience
- Flexible/remote work approach noted in company materials
Last updated Oct 21, 2026. Interested? Apply on the company site.
About Hims & Hers
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