# Compliance Pharmacist, Sterile Compounding

**Company**: Hims & Hers
**Location**: Mesa, Arizona
**Work arrangement**: onsite
**Experience**: senior
**Job type**: Full time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://jobs.ashbyhq.com/hims-and-hers/5e420212-5379-4574-81c7-ab7c764290b9?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

Hims & Hers is looking for a Compliance Pharmacist with sterile compounding expertise to serve as the PIC Designee for sterile compounding at our 503A pharmacy.

In this role, you’ll partner closely with the Pharmacist-in-Charge (PIC) to ensure our sterile compounding operations meet all applicable federal, state, and professional standards.

**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.

**Requirements:**

- 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.

**Nice to Have:**

- Prior experience serving as a Designated Person (DP) or PIC Designee.

- Experience in high-growth or regulated healthcare environments.

- Background in working with cross-functional teams including quality and legal.

- Advanced training or certification in sterile compounding or pharmacy quality.

## Skills

### Required
- Sterile compounding
- Pharmacy compliance
- Quality assurance
- USP <797>
- USP <800>
- State board of pharmacy regulations
- Audit support
- Regulatory inquiries

### Nice to have
- Designated Person (DP) or PIC Designee experience
- High-growth or regulated healthcare environments
- Cross-functional team collaboration
- Advanced training or certification in sterile compounding or pharmacy quality

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Source: [Apply at jobs.ashbyhq.com](https://jobs.ashbyhq.com/hims-and-hers/5e420212-5379-4574-81c7-ab7c764290b9?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)
