Lead Pharmacist, Compliance & Quality (USP 795/800)

OpenLoop Health; Daphne (AL); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending Accounts

Flexible PTO

401(k) + Company Match

Life Insurance

Pet insurance

Job summary

OpenLoop Health in Daphne, Alabama is seeking 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 and ensuring audit readiness.

You will manage environmental monitoring, CAPA, SOPs, training, deviations, CAPA, qualification records, and respond to inspections while collaborating with corporate compliance leadership.

Qualifications

• Active, unrestricted pharmacist license in the state of practice.
• B.S. in Pharmacy or Pharm.D. from 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.

Responsibilities

• Own day-to-day USP <795> and <800> (2023) compliance — keep operations current and audit-ready.
• Manage environmental monitoring: air sampling, particle and pressure/temperature/humidity tracking, CAPA.
• Maintain SOP library and train personnel on compliance procedures.
• Run training and competency program per USP <795>.
• Own the CAPA program — deviation documentation, root cause analysis, corrective action tracking.
• Maintain facility qualification records and calibration documentation.
• Coordinate USP <800> compliance: risk assessment and spill response readiness.
• Oversee MFR/CR completeness, BUD documentation, supplier qualification records.
• Conduct mock inspections and respond to findings from state boards, FDA, or accreditors.
• Manage product complaints, adverse event reporting, and recalls.

Skills

Regulatory compliance

USP <795>/<800>

CAPA management

Environmental monitoring

Documentation

Training & SOPs

Communication

Education

B.S. in Pharmacy or Pharm.D. (ACPE-accredited)

Tools

EM programs

CAPA systems

Deviation management

Job description

OpenLoop Health in Daphne, Alabama is seeking 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 and ensuring audit readiness.

You will manage environmental monitoring, CAPA, SOPs, training, deviations, CAPA, qualification records, and respond to inspections while collaborating with corporate compliance leadership.