Job Description

Job Description

Job Description

About the Job

The Staff Pharmacist is responsible to ensure adherence to state and federal regulations, and support all compounding, fill and post production activities as trained and assigned. Duties include support and limited oversight of business unit colleagues, ensure production goals are achieved, assist with investigations, assist in daily pharmacist duties, monitor training and work with training/compliance team to ensure all training is up to date. At the guidance of the Pharmacist in Charge (site dependent) the Staff Pharmacist will provide functional support during PTO, holidays, or situational emergencies for either the PIC or other Staff Pharmacist.

Key Responsibilities

• Responsible for the execution of opening and closing activities as requested from the PIC. Ensuring that strict procedures are followed around the facility. 
• Ensure production goals are created, tracked, and achieved. When not met, work with the PIC and operations leadership to ensure data driven action items are developed and executed on. 
• Identify trends or issues that are delaying batch production or causing batches to be cancelled.
• Authoring, or approving, operational and production SOP’s when applicable.
• Lead & Assist in documentation and completion of Adverse Drug Event forms.
• Answer clinical questions from health professionals and provide product information.
• Ensuring safe work environments, enforcing operational discipline, and monitoring aseptic behaviors. 
• Efficiently utilize 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.
• Understanding the importance/impact of cGMP standards. 
• Identifying potential process/product improvements and working collectively with cross-functional teams to implement process/procedure updates.
• Actively working within cross-functional teams in order to improve overall performance through sharing knowledge in related disciplines while solving moderately complex problems.
• Maintain state pharmacy license(s) for the facility, either directly or shared with other staff pharmacists to ensure compliance with all state licensing requirements.
• Responsible for state board licensing compliance, as assigned by the PIC or Director of Pharmacy Operations, to ensure business continuity in all 50 US states and the District of Columbia.
• Due to the rotational requirements of this position; the Staff Pharmacist will be responsible for:
• • Support post-production activities with on the floor as required from the PIC, with not less than 50% of the time on the floor.
  • Perform responsibilities associated with order fulfilment. 
  • Supervise aseptic operations staff, as required from the PIC; specific to West side operations. 

Basic Qualifications

• Maintain a pharmacist license in the state of Kansas that is in good standing and current. 
• Obtaining licensure in other states may be required to fulfil state specific regulatory obligations
• 3-5 years 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.
• 2-5 years management experience; with no fewer than 3 direct/indirect reports. 
• Proven effective verbal and written communication skills
• Experience working with standard ERP/MRP systems.
• Experience interpreting compliance requirements and regulations is required.
• Knowledge of DEA, FDA and state regulations pertaining to manufacturing and handling of controlled substances.
• Capable of lifting up to 50 pounds, standing for extended periods of time and shall have no allergies to chemicals that might be used during compounding. 
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. 
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. 
• Ability to effectively present information to top management, public groups, and/or boards of directors. 
• Ability to define problems, collect data, establish facts, and draw valid conclusions. 
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• 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 solution and take action.
• Previous experience working with auditors, inspectors, and regulatory agencies.
• Previous experience operating under FDA cGMP with a robust understanding of the principles and applications associated with manufacturing operations.
• Other duties as assigned

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Company Description

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

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