About the role
Overview
Responsible for overseeing daily sterile and non-sterile compounding operations, ensuring product quality, regulatory compliance, efficient production, and proper staff training.
Key Responsibilities
- Oversee daily compounding, production scheduling, batch documentation, and product release.
- Ensure compliance with USP <797>/<800>, pharmacy regulations, and established quality procedures.
- Manage inventory, materials, labeling, packaging, and final product verification.
- Review batch records, SOPs, deviations, investigations, and other quality documentation.
- Lead training, competency assessments, hiring, and performance management of pharmacy staff.
- Support formulation development and production of R&D batches.
- Partner with Quality and Operations on investigations, process improvements, and compliance initiatives.
- Maintain required pharmacy licenses, permits, and registrations.
- Serve as the technical resource for complex compounding and production matters.
Qualifications
- PharmD or RPh with an active, unrestricted pharmacist license.
- 3+ years of sterile and/or non-sterile compounding experience.
- 1+ year of supervisory or leadership experience.
- Experience with sterile injectables and aseptic techniques preferred.
- Knowledge of USP <797>/<800>, SOP development, and quality systems.
- Strong leadership, communication, organizational, and problem-solving skills.
Work Environment
Cleanroom, laboratory, pharmacy, and production settings. Requires extended standing, lifting up to 15 lbs., and adherence to gowning, safety, and contamination-control procedures.
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