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The Sterile Pharmacy Assistant Manager assists the Sterile Pharmacy Manager to provide strategic and operational leadership for the sterile compounding program, ensuring the highest standards of patient-centered care, regulatory compliance, and quality assurance. This role oversees daily sterile compounding operations, manages and develops pharmacy staff, and ensures strict adherence to USP <797>, cGMP, and all applicable state and federal regulations. The Sterile Pharmacy Assistant Manager is responsible for verifying patient-specific prescriptions, validating compounded lots, and ensuring consistent compliance with Strive Pharmacy Standard Operating Procedures (SOPs).
Job Responsibility:
Provide direct leadership, supervision, and performance management for sterile compounding personnel
Oversee staffing, scheduling, onboarding, and ongoing competency assessments
Foster a culture of safety, quality, accountability, and continuous improvement
Assist in the development, implementation, and periodic review of sterile compounding SOPs
Coordinate cross-departmental communication to support efficient workflow and compliance
Serve as a primary point of contact for operational, personnel, compliance, and regulatory matters within the sterile compounding department
Ensure accurate verification of prescriptions, compounded lots, and batch records
Review and approve proprietary sterile formulations and ensure proper adherence to compounding procedures
Perform or oversee required calculations to ensure ingredients are measured and utilized accurately
Ensure appropriate quality control measures, including visual verification, photographic documentation, and inspection of sterile laboratory work
Lead and participate in regular audits, environmental monitoring, and regulatory inspections
Oversee cleanliness, maintenance, and readiness of the compounding lab in accordance with SOPs and regulatory requirements
Ensure proper maintenance, calibration, and documentation of equipment such as scales, balances, and electronic meters
Monitor inventory for outdated or soon-to-expire chemicals and supplies
Ensure strict adherence to USP <797>, USP <795>, USP <800>, 503B Guidance, 21 CFR 211 (cGMP), and other applicable regulatory standards
Maintain and enforce policies related to aseptic technique, gowning procedures, and controlled environment requirements
Drive continuous quality improvement initiatives and corrective/preventive actions (CAPA)
Develop, deliver, and track ongoing training and competency programs for pharmacy personnel
Provide mentoring and leadership development for team members
Requirements:
Bachelor of Science (BS) in Pharmacy or Doctor of Pharmacy (PharmD)
Active Pharmacist license in good standing in state of the pharmacy
Minimum of 1-2 years prior leadership or supervisory experience in a sterile compounding or pharmacy production environment required
One or more years of hands-on sterile compounding experience preferred
Strong knowledge of USP <797>, USP <795>, USP <800>, and cGMP/503B guidelines
Understanding of medical terminology and pharmacy calculations
High attention to detail and commitment to accuracy and potency standards
Ability to manage teams in a fast-paced, highly regulated environment
Ability to work with delicate and specialized equipment to produce sterile dosage forms
Must be capable of donning and wearing full sterile protective equipment as required (mask, gloves, lab coat, coveralls, hairnet, safety goggles, shoe covers)
Knowledge of fundamental principles, laws, policies, and procedures relevant to sterile compounding and cGMP