Senior Pharmacist, USP Compliance & Quality Assurance

Alt

Stockton (CA)

Hybrid

USD 140,000 - 170,000

Full time

14 days+

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Benefits offered by this job

Medical, Dental and Vision plans
Flexible PTO
401(k) + Company Match
Life Insurance
HSA/FSAs

Job summary

California Quality Pharmacy, a Stockton, CA sterile compounding facility, seeks a Lead Pharmacist, Pharmacy Compliance to own USP <795>, <797>, and <800> programs and maintain inspection readiness. You will coordinate CAPA, environmental monitoring, SOPs, and training, interfacing with centralized leadership.

The role requires strong regulatory expertise, 503A experience, and a hands-on approach to ensure continuous compliance and quality across operations.

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>, <797>, and <800> (2023).
  • Hands-on experience with EM programs, deviation management, or CAPA systems.

Responsibilities

  • Own day-to-day USP <795>, <797>, <800> compliance — keep operations, controls, personnel practices, and quality systems audit-ready.
  • Manage environmental monitoring program: viable air/surface sampling and parameter tracking.
  • Maintain SOP library — draft, update, version-control, train personnel on procedures.
  • Lead personnel training and competency program per USP <797> Section 7.
  • Own the site CAPA program — deviation documentation, root cause analysis, corrective actions, closure.

Skills

USP compliance
Regulatory knowledge
Documentation
CAPA & deviations
Training & coaching

Education

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

Tools

EM programs
CAPA systems

Job description

California Quality Pharmacy, a Stockton, CA sterile compounding facility, seeks a Lead Pharmacist, Pharmacy Compliance to own USP <795>, <797>, and <800> programs and maintain inspection readiness. You will coordinate CAPA, environmental monitoring, SOPs, and training, interfacing with centralized leadership.

The role requires strong regulatory expertise, 503A experience, and a hands-on approach to ensure continuous compliance and quality across operations.

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