Sterile Lab Assistant Manager

Strive PharmacySaint Louis, MO
10dOnsite

About The Position

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).

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.
  • 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.

Nice To Haves

  • One or more years of hands-on sterile compounding experience preferred.
  • Board Certified Sterile Compounding Pharmacist (BCSCP).
  • Experience in pharmacy production environments (503A or 503B).
  • Advanced understanding of aseptic technique.
  • Demonstrated ability to oversee audits, inspections, and regulatory reviews.
  • Strong working knowledge of state and federal pharmacy regulations related to sterile compounding.

Responsibilities

  • 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.
  • Complete required sterile compounding continuing education.
  • Provide mentoring and leadership development for team members.

Benefits

  • Strive Pharmacy provides a comprehensive benefits package that encompasses various perks such as employer paid healthcare coverage available after 30 days of employment, the choice of an FSA/HSA, a voucher for new hire scrubs (if applicable), parental leave, a 401(k) plan with matching contributions, and the benefit of weekends and holidays off.
  • FREE COMPOUNDED MEDS to employees and immediate family members.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Number of Employees

501-1,000 employees

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