Lead Pharmacist, Pharmacy Compliance

OpenLoop Health, Inc; Stockton (CA); Presencial; USD 140.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, and Vision plans

Flexible Spending/Health Savings

Flexible PTO

401(k) + Company Match

Life Insurance

Pet insurance

Descripción de la vacante

OpenLoop Health, Inc. is seeking a Lead Pharmacist, Pharmacy Compliance to serve as the on-site compliance authority at our licensed compounding facility.

You will own USP <795>, <797>, and <800> program execution, maintain inspection readiness, and act as the primary interface between site operations and corporate compliance leadership. You will lead environmental monitoring, CAPA, training, SOP management, and documentation controls to ensure adherence to USP standards and

Formación

• Active, unrestricted pharmacist license in the state of practice.
• 3+ years in compounding pharmacy operations or pharmaceutical QA at a licensed 503A facility.
• Working knowledge of USP <795>, <797> and <800> (2023).
• Hands-on experience with EM programs, deviation management, or CAPA systems.

Responsabilidades

• Own day-to-day USP <795>, <797>, and <800> compliance—keeping operations, controls, personnel practices, and quality systems current, documented, and audit-ready.
• Manage the environmental monitoring program: viable air and surface sampling, non-viable particle tracking, and CAPA.
• Maintain the SOP library—draft, update, version-control, and train personnel on all compliance-related procedures.
• Run the personnel training and competency program per USP <797> Section 7: initial and ongoing assessments, media fill, garbing, and remediation.
• Own the site CAPA program—deviation documentation, root cause analysis, corrective action tracking to closure, and trend reporting to leadership.
• Maintain facility qualification records: ISO certification schedules, equipment re-qualification triggers, and calibration documentation.
• Coordinate USP <800> compliance: engineering controls, PPE protocols, risk assessment, and spill response readiness.
• Oversee MFR/CR completeness, BUD documentation, incoming material/COA review, and supplier qualification records.
• Conduct mock inspections and gap assessments; support response to state board, FDA, or accreditation survey findings.
• Manage product complaints, adverse event reporting, and site-level recall procedures.
• Other duties as assigned.

Conocimientos

Collaborative communicator

Risk-based thinking

Self-directed

Regulatory understanding

Educación

B.S. in Pharmacy or Pharm.D.

Herramientas

EM programs

CAPA systems

Environmental monitoring

Descripción del empleo

About OpenLoop

OpenLoop was co-founded by CEO, Dr. Jon Lensing, and COO, Christian Williams, with the vision to bring care anywhere. Our telehealth support solutions are thoughtfully designed to streamline and simplify go-to-market care delivery for companies offering meaningful virtual support to patients across an expansive array of specialties, in all 50 states.

About the Role

OpenLoop is looking for aLead Pharmacist, Pharmacy Compliance to serve as the on-site compliance authority at its licensed compounding facility - owning USP <795>, <797>, and <800> program execution, maintaining inspection readiness, and acting as the primary compliance interface between the site and centralized pharmacy leadership. This role reports directly to the corporate compliance leadership team.

What You'll Do

• Own day-to-day USP <795>, <797>, and <800> (2023) compliance - keeping operations, controls, personnel practices, and quality systems current, documented, and audit-ready.
• Manage the environmental monitoring program: viable air and surface sampling, non-viable particle and pressure/temperature/humidity tracking, action level investigation, and CAPA.
• Maintain the SOP library - draft, update, version-control, and train personnel on all compliance-related procedures.
• Run the personnel training and competency program per USP <797> Section 7: initial and ongoing assessments, media fill, gloved fingertip sampling, garbing, and remediation.
• Own the site CAPA program - deviation documentation, root cause analysis, corrective action tracking to verified closure, and trend reporting to leadership.
• Maintain facility qualification records: ISO certification schedules, equipment re-qualification triggers, and calibration documentation.
• Coordinate USP <800> compliance: engineering controls, PPE protocols, Assessment of Risk, and spill response readiness.
• Oversee MFR/CR completeness, BUD documentation, incoming material/COA review, and supplier qualification records.
• Conduct mock inspections and gap assessments; support response to state board, FDA, or accreditation survey findings.
• Manage product complaints, adverse event reporting, and site-level recall procedures.
• Other duties as assigned.

Who You Are

• B.S. in Pharmacy or Pharm.D. from an ACPE-accredited institution with an active, unrestricted pharmacist license in the state of practice.
• Additional state pharmacist licensure is beneficial, but not required
• 3+ years of hands-on experience in sterile compounding operations or pharmaceutical QA at a licensed 503A facility or 5+ years in pharmaceutical quality/compliance without direct 503A experience, with commitment to complete USP training in 90 days.
• Practical command of USP <795>, <797> and <800> (2023) - EM programs, competency requirements, and quality systems.
• Experience with deviation investigations, CAPA, and environmental monitoring data analysis.
• Disciplined documenter, risk-based thinker, and self-directed - able to manage competing compliance obligations without close oversight.
• Collaborative communicator who can translate regulatory requirements into clear operational direction for staff and escalation clearly to leadership.

Required Qualifications

• Active, unrestricted pharmacist license in the state of practice.
• B.S. in Pharmacy or Pharm.D. from an ACPE-accredited institution.
• 3+ years in compounding pharmacy operations or pharmaceutical QA at a licensed 503A facility.
• Working knowledge of USP <795>, <797> and <800> (2023).
• Hands-on experience with EM programs, deviation management, or CAPA systems.

Preferred Qualifications

• Experience at a state-licensed 503A sterile compounding pharmacy.
• Familiarity with state board inspection processes and sterile compounding enforcement.
• ISO 5/7/8 cleanroom classification and NABP/PCAB accreditation experience.
• Experience responding to inspection observations, FDA Form 483s, or voluntary disclosures.
• Familiarity with compounding regulatory landscape.

Our Benefits

In addition, for salaried positions you would also be eligible for:

• Medical, Dental, and Vision plans
• Flexible Spending/Health Savings Accounts
• Flexible PTO
• 401(k) + Company Match
• Life Insurance, Pet insurance, and more

Our Company

We have a relatively flat organizational structure here at OpenLoop. Everyone is encouraged to bring ideas to the table and make things happen. This fits in well with our core values of Autonomy, Competence and Belonging, as we want everyone to feel empowered and supported to do their best work.

Sound like a good fit? We'd love to meet you.