Compliance Pharmacist, Sterile Compounding
On-site · New Albany, Ohio, United States
Job Summary
Compliance Pharmacist with sterile compounding expertise to serve as the Designated Person for a 503A pharmacy. Lead regulatory compliance and quality initiatives to ensure USP <797>/<800>, state board requirements, and internal policies are met; design and maintain self-inspection programs; support licensure and regulatory readiness across jurisdictions; oversee aseptic technique, environmental controls, cleaning, and disinfection in partnership with Quality; review SOPs and documentation for regulatory alignment; monitor regulatory changes and implement impact across operations; participate in investigations, CAPA development, and audits/inspections; collaborate with PIC, QA, training, and leadership to manage compliance risks and maintain high standards of patient safety. Requires a pharmacy degree from an ACPE-accredited school, active pharmacist license, and 2 years of sterile compounding experience; willing to travel.
Required Qualifications
- 2 years of Sterile compounding experience
- Pharmacy degree from an ACPE-accredited school of pharmacy
- 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
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