Position Summary
The Full-Time Pharmacist supports Medivant's sterile injectable manufacturing operations by ensuring all compounding, labeling, and documentation processes comply with FDA regulations, USP <797>/<800>, and internal SOPs.
This role involves verifying batch records, supervising compounding operations, ensuring quality assurance compliance, and overseeing controlled substance handling as required.
This is a full-time position offering long-term career growth, stability, and the opportunity to work in a highly regulated cGMP manufacturing environment.
Key Responsibilities
- Review and approve batch production records, labels, and associated documentation
- Supervise sterile compounding and aseptic filling operations to ensure compliance with USP <797>/<800> standards
- Verify and document calculations for compounding and formulation accuracy
- Monitor cleanroom operations, gowning compliance, and aseptic techniques
- Support internal and regulatory audits, CAPA investigations, and validation activities
- Ensure compliance with DEA, FDA, and state pharmacy board regulations
- Collaborate with Quality Assurance and Production teams to maintain continuous compliance
- Provide guidance to technicians and operators on cGMP and pharmacy standards
- Participate in review of deviations, investigations, and process improvements
Qualifications
Required:
- Active Pharmacist License in the state of Arizona (in good standing)
- Minimum 2-3 years of experience in sterile compounding, manufacturing pharmacy, or 503B facility
- Strong understanding of USP <797>, USP <800>, cGMP, and FDA manufacturing guidelines
- Strong documentation, verification, and analytical skills
- Excellent communication and teamwork abilities
Preferred:
- Experience in sterile injectable production or pharmaceutical quality assurance
- Familiarity with LIMS, ERP, or electronic batch record systems
- Prior experience in a 503B outsourcing facility or hospital cleanroom setting
Compensation & Benefits
- Competitive base salary (based on experience)
- Health, dental, and vision insurance
- Paid time off (PTO) and holidays
- Opportunities for career growth and advancement
- Stable, long-term employment with a growing organization