Lead Pharmacist, USP Compliance & QA Leader

OpenLoop Health, Inc; Daphne (AL); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Medical plans

Dental plans

Vision plans

FSA/HSA

Flexible PTO

401(k) + Match

Life Insurance

Pet Insurance

Job summary

OpenLoop Health, Inc. seeks a Lead Pharmacist, Pharmacy Compliance to serve as the on-site compliance authority at its non-sterile licensed compounding facility.

This role owns USP and program execution, maintains inspection readiness, and interfaces with centralized pharmacy leadership. The ideal candidate has 3+ years in sterile compounding or QA in a licensed 503A setting, with strong USP training and CAPA experience.

Qualifications

• 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> and <800> (2023).
• Hands-on experience with EM programs, deviation management, or CAPA systems.

Responsibilities

• Own day-to-day USP <795> and <800> compliance, keeping operations, controls, personnel practices, and quality systems audit-ready.
• Manage the environmental monitoring program: viable air sampling, particle tracking, and trend reporting to leadership.
• Maintain the SOP library and train personnel on compliance procedures.

Skills

Regulatory compliance

Pharmacy licensure

GxP knowledge

CAPA management

Environmental monitoring

Documentation

Education

B.S. in Pharmacy or Pharm.D.

Tools

EM programs

CAPA systems

Job description

OpenLoop Health, Inc. seeks a Lead Pharmacist, Pharmacy Compliance to serve as the on-site compliance authority at its non-sterile licensed compounding facility.

This role owns USP and program execution, maintains inspection readiness, and interfaces with centralized pharmacy leadership. The ideal candidate has 3+ years in sterile compounding or QA in a licensed 503A setting, with strong USP training and CAPA experience.