Buy-Rite Drugs (BRD), a leader in the equine compounding community located in Hartselle, AL., is seeking a mission-focused and energetic leader who is enthusiastic about making a difference in the lives of animals large and small for our 797 Department Manager position. The 797 Department Manager will be responsible for overseeing all activities related to the 797 department including, but not limited to, scheduling, compounding, inventory control, and quality assurance documentation. In addition, the 797 Department Manager will provide leadership to 797 staff in key aspects of sterile compounding. The 797 Manager will also assist the leadership team preparing for and during inspections.
The ideal candidate will possess highly effective interpersonal and collaborative skills, excellent writing and verbal communication, and the utmost attention to detail. This role is a fit for highly organized individuals who can complete multiple tasks and deliverables within tight timelines and can prioritize for periods with competing priorities.
JOB FOCUS AREA: Operations
1. USP <797> Compliance:
o Ensure all sterile compounding activities comply with USP <797> guidelines, including environmental monitoring, cleaning protocols, and personnel training.
o Develop and implement policies and procedures for sterile compounding and cleanroom operations.
2. Aseptic Technique Management:
o Train and evaluate pharmacy staff on aseptic techniques.
o Monitor compliance with garbing, hand hygiene, and other aseptic procedures and verify by conducting gloved fingertip sampling in accordance with USP <797> and facility SOPs.
3. Cleanroom Oversight:
o Oversee the maintenance and operation of the cleanroom facilities, ensuring ISO-classified conditions are met.
o Manage cleaning, disinfection, and maintenance schedules for cleanroom equipment and facilities.
4. Environmental Monitoring:
o Perform and document surface sampling as part of environmental monitoring protocols.
o Identify and address any contamination risks or deviations promptly.
5. Sterile Compound Preparation:
o Oversee the compounding of sterile medications ensuring technicians are following appropriate formulas and regulatory requirements.
o Conduct and oversee final preparation checks to ensure sterility, potency, and accuracy.
6. Documentation and Reporting:
o Maintain accurate records of compounding activities, testing results, and deviations.
o Prepare reports for internal audits and regulatory inspections.
7. Regulatory Compliance:
o Stay updated on USP <797>, <800>, and other applicable standards.
o Prepare for and participate in regulatory inspections and audits.
8. Quality Assurance:
o Oversee quality control testing for compounded sterile preparations, including endotoxin testing and sterility testing.
o Conduct risk assessments and address corrective actions for non-compliance.
9. Inventory and Supplies Management:
o Ensure availability of sterile compounding supplies and materials including APIs. Notify purchaser immediately if insufficient inventory.
o Oversee inventory control for sterile compounding ingredients.
10. Training and Development:
o Develop and deliver training programs for pharmacy staff on USP <797> standards and aseptic techniques.
o Conduct annual competencies and evaluations for personnel involved in sterile compounding.
o Complete and oversee Critical Point Training for required CE credit.
11. Organizational Health:
o Coach 797 department staff to ensure KRAs are being met
o Lead daily stand-up meetings for department
o Lead weekly 1-on-1 meetings with your direct reports
Qualifications
- Doctor of Pharmacy (Pharm.D.) or Bachelor of Pharmacy (BPharm) degree.
- Active pharmacist license in the relevant state.
- Certification in sterile compounding (e.g., ACPE certification or other specialize training) preferred.
- Comprehensive knowledge of USP <797> and USP <800> guidelines.
- Experience in sterile compounding and cleanroom operations preferred.
SKILLS AND ABILITIES:
- Strong understanding of aseptic techniques and environmental monitoring.
- Attention to detail and commitment to quality assurance.
- Ability to lead and train staff in sterile compounding practices.
- Excellent organizational, documentation, and problem-solving skills.
- Familiarity with regulatory standards (FDA, USP, and state boards of pharmacy).
SALARY AND BENEFITS
Dependent on experience. In addition to a competitive base salary, we offer statutory benefits required by law. Company sponsored 401(k) is available.
Buy-Rite Drugs is an Equal Opportunity Employer
Equal Employment Opportunity and Non-Discrimination Statement
We offer equal opportunity to all job applicants and employees regardless of race, color, age, gender, religion, marital status, and sexual orientation. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential job functions.
Job Type: Full-time
Pay: $110,000.00 - $125,000.00 per year
Benefits:
- 401(k) matching
- Paid time off
- Professional development assistance
- Retirement plan
Work Location: In person
