Supervise Pharmacist

Job Description: Supervise Pharmacist (PIC), 503B Outsourcing Facility

The primary responsibility of the Supervise Pharmacist (Pharmacist in Charge) is to ensure adherence to facility SOP’s and procedures, adherence to state and federal regulations, and directly supervise pharmacists. The Supervise Pharmacist will work directly with Aseptic Operations Director/Manager to ensure production goals are achieved, assist with investigations, assist in daily operational pharmacy duties, monitor training and work with training/compliance team to ensure all training is up to date.

Under indirect supervision, oversees all aspects of the pharmacy operations. To assure that all services comply with professional standards and applicable laws. Exercises broad judgment in professional field requiring extensive subject matter knowledge and expertise, while keeping senior leadership fully informed of operating issues and results.

Role Responsibilities:

• Responsible for the execution of opening and closing activities; either directly, or through delegation to a staff pharmacist. Ensures that strict procedures are followed in the facility.
• Represents the facility in all state and federal regulatory audits, visits, and communications.
• Directly supervises staff pharmacists.
• Works with Cleanroom Operations Director/Manager to ensure production goals are created, tracked, and met. Identifies trends or issues that are delaying batch production or causing batches to be cancelled.
• Writes operational and production SOP’s.
• Liaisons with the quality department.
• Ensures compliance with all state and federal regulatory agencies.
• Assists in documentation and completion of Adverse Drug Event forms.
• Answers clinical questions from health professionals and provides product information.
• Supports order verification within computer order processing queues to ensure facility and product accuracy.
• Reviews all batch records and associated documentation verification.
• Ensures safe work environments, enforces operational discipline, and monitors aseptic behaviors.
• Efficiently utilizes tools and metrics (KPI’s) to monitor staff productivity, deliverables, timelines, and quality of work product to adjust staffing levels and operational processes as needed to ensure operational effectiveness.

Profile/Experiences:

• Understands the importance/impact of cGMP standards.
• Maintains California Pharmacist License. 
• Obtains licensure in other states which may be required to fulfill state specific regulatory obligations.
• Has strong analytical abilities coupled with creative problem-solving skills.
• Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Able to establish robust processes, develop performance standards, track performance through fact driven exercises, and implement solutions to drive continuous process improvements.
• Demonstrates skills to solve complex problems in a wide variety of high-pressure situations which require a high degree of ingenuity, creativity, and innovativeness.
• In situations where precedent may not exist, is able to independently exercise judgment, determine appropriate solutions and take action.
• Shows a history of mentoring and promoting the professional growth of healthcare colleagues.
• Accrued at least 10 years of pharmacy experience and a good understanding of quality and compliance requirements pertaining to cGMP and 21 CFR 210 & 211. 
• Prefer experience with a manufacturing environment specifically 503B Outsourcing Facility.  
• Previous experience operating under FDA cGMP with a robust understanding of the principles and applications associated with manufacturing operations.
• Experience interpreting compliance requirements and regulations is required.
• Knowledge of DEA, FDA and state regulations pertaining to manufacturing and handling of controlled substances.