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OpenLoop, a telehealth support solutions company, is hiring a Lead Pharmacist for Pharmacy Compliance at California Quality Pharmacy's licensed compounding facility in Stockton, CA. This role serves as the on-site compliance authority, reporting directly to corporate compliance leadership.
You will own day-to-day execution of USP <795>, <797>, and <800> (2023) compliance standards, ensuring operations, controls, personnel practices, and quality systems remain current, documented, and audit-ready. Key responsibilities include managing the environmental monitoring program (viable air and surface sampling, particle tracking, action level investigation, and CAPA); maintaining and updating the SOP library with version control and staff training; running the personnel training and competency program including initial assessments, media fill, gloved fingertip sampling, and garbing protocols; owning the site CAPA program with deviation documentation, root cause analysis, and trend reporting; maintaining facility qualification records including ISO certification schedules and equipment re-qualification; coordinating USP <800> compliance for engineering controls, PPE protocols, and spill response; overseeing MFR/CR completeness and BUD documentation; conducting mock inspections and gap assessments; managing product complaints and adverse event reporting; and supporting state board, FDA, or accreditation survey responses.
Required: B.S. in Pharmacy or Pharm.D. from ACPE-accredited institution with active, unrestricted pharmacist license in state of practice; 3+ years hands-on experience in sterile compounding operations or pharmaceutical QA at a licensed 503A facility (or 5+ years in pharmaceutical quality/compliance with commitment to complete USP training within 90 days); practical command of USP standards and EM programs; experience with deviation investigations and CAPA; disciplined documentation and risk-based thinking; collaborative communication skills.
Preferred: State-licensed 503A sterile compounding pharmacy experience; familiarity with state board inspection processes; ISO cleanroom classification and NABP/PCAB accreditation experience; experience responding to FDA Form 483s or voluntary disclosures.
