Quality and Compliance Pharmacist-Sterile Compounding

Job Type: Full-Time

Location: St. Louis, MO

Job Overview: On-Site Clean specializes in providing critical services in sterile cleanroom environments, including cleaning, USP competency assessments, monthly environmental monitoring, and full cleanroom certification services to pharmacy clients across multiple states in the Midwest.

The Quality and Compliance pharmacist requires a highly detail-oriented person to lead the Quality Assurance (QA) Program and compliance needs of the company. The role will be responsible for being the internal and external subject matter expert in USP compounding chapters as well as state and federal regulations. The position will play an active role in service offerings and client relations. This position will have direct reports to manage and guide.

Essential Duties and Responsibilities:

• Maintain detailed knowledge and comply with all, federal, state, and USP compounding regulations, standards for 503A and 503B Pharmacies, and CETA CAGs.
• QA Program ownership: Further develop, manage and continuously improve the program.
• SOP and Policy management: Track, write, review, revise, train, and enforce SOPs and policies.
• Supervise other personnel performing sterile compounding observation services.
• Conduct internal and client USP competency assessments. This includes gloved fingertip and thumb sampling, media fill simulations/aseptic evaluation manipulations and surface sample competencies.
• Act as trusted advisor for client relations and inquiries related to best practices and services.
• Manage and monitor internal training materials for initial, ongoing and any ad-hoc training sessions.
• Manage procedures for handling, collecting and incubating growth media devices and samples.
• Manage documentation, including training records, temperature logs and equipment calibrations.
• Follow good documentation practices on all required forms and logs.
• Conduct surface sampling collection within ISO classified compounding rooms or segregated compounding areas.
• Assist with managing operations, including portal management, client engagement and project execution.
• Assist with vendor management and communications.
• Support continuous improvement initiatives locally and company-wide.
• Comply with On-Site Clean and client policies.
• Ability to communicate effectively to pharmacy technicians, pharmacists and pharmacy leadership as needed.
• Participate in in-service education programs provided or sponsored by On-Site Clean.
• Perform other duties as assigned by your supervisor.
• Stay current with industry trends and advancements in sterile compounding practices.

Education and/or Work Experience Requirements:

• A minimum of 2 years of sterile compounding experience is required.
• Active, unrestricted pharmacist license in good standing.
• Current knowledge of USP <795>, <797> and <800> compounding standards.
• Current knowledge of all applicable state and federal pharmacy laws, rules, and regulations (503A and 503B).
• Experience with quality assurance and quality control in a pharmacy setting.
• Process oriented with analytical mindset for root cause analysis needs.
• Excellent attention to detail and organizational skills.
• Effective interpersonal, time management, and organizational skills.
• Proficient with computer software such as Adobe, Microsoft suite.
• Excellent customer service skills.

Physical Requirements:

• The employee is regularly required to stand, walk, and sit when visiting various pharmacy locations.
• The employee may be required to use a computer screen for long periods of time.
• The employee will need to be able to wear Personal Protective Equipment (PPE) for long periods of time, including a respirator.
• The employee will work in hazardous drug compounding areas that may require additional PPE.

Additional Requirements:

• Position work hours are generally Monday through Friday during normal business hours with occasional evenings and weekends as needed per client request.
• Will require travel to various pharmacy locations across the St. Louis Metro area.
• May require travel to out of state for training or client needs.
• If not at a client site, the position will report to the main office located in Fenton, MO.
• A positive growth mindset as the business scales.

Benefits:

• Health Insurance
• Dental Insurance
• Vision Insurance
• 401(k)
• Life insurance
• Vacation Time Off
• Paid Time Off (PTO)
• 6 Paid Holidays Off

Pay: From $125,000.00 per year

Work Location: In person

Salary : $125,000