Sterile Lab Pharmacist

General Job Description: The Sterile Lab Pharmacist oversees and ensures compliance with all sterile compounding operations within Designer Drugs’ state-of-the-art laboratory. This role requires a highly skilled and detail-oriented pharmacist with expertise in USP <797>and USP <800> standards, aseptic techniques, and regulatory compliance. The Sterile Lab Pharmacist works under the direct supervision of the QAQC Director and plays a crucial role in maintaining the highest standards of safety, efficacy, and quality in sterile compounded preparations

KEY RESPONSIBILITIES:

Sterile Compounding Oversight

• Lead and oversee all sterile compounding activities, ensuring compliance with USP <797>, USP <800>, and FDA regulations.
• Maintain sterile lab environment, ensuring adherence to proper gowning, cleanroom procedures, and aseptic techniques.
• Monitor and enforce sterility assurance controls, including environmental monitoring, personnel testing, and media-fill testing.
• Ensure accurate preparation, labeling, and verification of sterile injectable, ophthalmic, and intrathecal preparations.

Regulatory Compliance & Quality Assurance:

• Collaborate with the QAQC Director to implement and maintain all Standard Operating Procedures (SOPs) related to sterile compounding.
• Conduct routine quality control testing, sterility testing, and endotoxin testing to ensure product integrity.
• Maintain compliance with state and federal pharmacy laws, FDA regulations, DEA requirements, and compounding pharmacy accreditation standards.
• Participate in internal and external audits, ensuring complete documentation and adherence to all quality measures.
• Participate and lead continuous quality improvement assessment & implementation (CQI)

Team Leadership & Training:

• Train and mentor pharmacy technicians on aseptic techniques, proper handling of hazardous drugs, and adherence to SOPs.
• Oversee and evaluate technician performance in sterile compounding procedures.
• Provide continuing education to staff on regulatory updates, new sterile compounding techniques, and laboratory best practices.

Inventory & Laboratory Management:

• Manage inventory of sterile compounding ingredients, ensuring proper storage, tracking, and disposal of hazardous substances.
• Coordinate calibration, maintenance, and validation of sterile compounding equipment such as laminar flow hoods, isolators, autoclaves, and cleanroom HVAC systems.
• Implement continuous improvement initiatives to enhance operational efficiency, sterility assurance, and patient safety.

Patient Safety & Risk Management:

• Evaluate and validate prescriptions for clinical appropriateness, compatibility, and stability before sterile compounding.
• Work with physicians and healthcare providers to ensure compounded medications meet individual patient needs.
• Investigate and report adverse drug events, sterility failures, or contamination incidents, implementing corrective actions and preventative actions with appropriate trending and documentation.

QUALIFICATIONS & REQUIREMENTS:

• PharmD
• Active Pharmacist license in the state of Tennessee, in good standing.
• Minimum 2 years of experience in sterile compounding pharmacy, hospital cleanroom, or 503A/503B outsourcing facility.
• Extensive knowledge of USP <797>, USP <800>, cGMP, and FDA requirements for sterile compounding.
• Certification in Sterile Compounding and Aseptic Processing (preferred).
• Strong leadership, communication, and problem-solving skills.
• Ability to thrive in a fast-paced, high-compliance environment.
• Experience with electronic compounding software, inventory management systems, and laboratory documentation protocols.

PHYSICAL & WORK ENVIRONMENT REQUIREMENTS:

• Ability to stand for extended periods, wear full sterile garb, and work in a cleanroom environment.
• Capacity to lift and handle compounding materials and equipment up to 50 lbs.
• Exposure to hazardous drugs, sterile solutions, and cleanroom-grade disinfectants.

ATTIRE:

• Scrubs, lab-approved shoes, and company name tag provided by Designer Drugs

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday
• No nights
• No weekends

Education:

• Doctorate (Required)

License/Certification:

• Licensed Pharmacist (Required)