Lead Pharmacist, Pharmacy Compliance

Alt; Daphne (AL); Hybrid; USD 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

Medical, Dental & Vision plans

Flexible Spending/Health Savings

Flexible PTO

401(k) + Company Match

Life Insurance & Pet insurance

Zusammenfassung

Triad Rx is seeking a Lead Pharmacist, Pharmacy Compliance to act as the on-site compliance authority at its Daphne, AL facility. You will own USP <795> and <800> program execution, ensure audit-ready operations, and serve as the primary interface with centralized leadership.

Responsibilities include managing environmental monitoring, SOP maintenance, training, CAPA, and regulatory communications. A strong background in sterile compounding QA and regulatory readiness is required.

Qualifikationen

• Active, unrestricted pharmacist license in the state of practice.
• 3+ years in compounding or pharmaceutical QA at a licensed facility.
• Hands-on experience with USP <795> and <800> (2023).
• Experience with deviation investigations, CAPA, or regulatory data analysis.

Aufgaben

• Own day-to-day USP <795>/<800> compliance and keep operations auditable.
• Manage environmental monitoring: air sampling, particle tracking, and instrument calibration.
• Maintain SOP library with updates and training.
• Lead personnel training and competency assessments per USP <795>.
• Own CAPA program: deviation handling, root cause analysis, corrective actions, and trend reporting.

Kenntnisse

Regulatory compliance

USP <795>/<800> knowledge

Quality systems

Environmental monitoring

CAPA management

Ausbildung

B.S. in Pharmacy or Pharm.D.

Tools

CAPA systems

EM programs

Jobbeschreibung

About the Role

Triad Rx is looking for a Lead Pharmacist, Pharmacy Compliance to serve as the on-site compliance authority at its non-sterile licensed compounding facility— owning USP <795>, 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> and <800> (2023) compliance — keeping operations, controls, personnel practices, and quality systems current, documented, and audit-ready.

• Manage the environmental monitoring program: viable air 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 <795>: initial and ongoing assessments 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: Hazardous room 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> and <800> (2023) — EM programs, competency requirements, and quality systems.

• Experienced 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 elevate 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> 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 sterile US 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

Join Triad Rx, a growing 503A compounding pharmacy based in Daphne, Alabama. We specialize in non-sterile pharmaceutical compounding, delivering high-quality, patient-specific medications with a strong commitment to regulatory compliance and clinical excellence. As we continue to expand, we're looking for dedicated professionals who take pride in precision and patient care.