Pharmacist In Charge New Providence NJ 503 B
Healthcare consultants Pharmacy Staffing (HCC) is seeking well qualified Pharmacist candidates, with New Jersey licensure, experience with Compounding USP 797-USP 800, experience with 503 B outsourcing, and experience as a Pharmacist In Charge. This position is for Pharmacist In Charge, Compounding Pharmacist 503 B and is with a start-up 503 B outsourcing pharmacy located in Providence, New Jersey.
Compensation is competitive, commensurate with experience and skills. Benefits are: Health, Dental, Vision, and Retirement Plan.
• Develop and implement comprehensive strategies for formulation and packaging development of drug products.
• Product development and compounding.
• Ensure that procedures are followed and consistent with cGMPs.
• Review and approve master batch records, executed batch records, manufacturing deviations and investigations.
• Generate and/or review Process Validation documentation, including Product Validation Master Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols.
• Lead, structure, and plan the management of sterile and non-sterile compounding to achieve product quality, on-time delivery, effective inventory management and manufacturing productivity
• Effectively manage, train, and motivate all direct and indirect subordinates to maximize the overall productivity of operations
• Responsible for maintaining an efficient workflow between all pharmacy functions. Keeps priority on key metrics related to service levels, deviations/CAPA, other operational efficiencies, inventory/distribution metrics, capital/resource utilization and for resolving conflicts
• Ensure facility is maintained in a constant state of inspection readiness ensuring that all staff are compliant with cGMP and all related elements such as facilities, documentation (SOPs and validation protocols etc.), training, reports, and records.
• Manage supply chain logistics for drug product manufacturing activities.
• Assists with additional work duties or responsibilities as evident or required.
• Ensure safety throughout operations and identify preventative plans to prevent accidents
• Ensuring that all equipment, as proscribed through regulation is available and in good working order
• Provide management with routine updates regarding the productivity and efficiency of operations
• Initiate recommendations on purchasing of new equipment and improvements
• Create a culture of continuous improvement and provide coaching and mentorship
• Performs other duties as assigned or apparent.
NOTE: The primary accountabilities below describe the general content of and requirements of this position. This is not an exhaustive statement of duties.
• Write, review and update – batch records, SOPs, and other cGMP documents.
• Manage and communicate with FDA.
• Lead inspections, accreditations and other regulatory requirements.
• Quality control
• Optimize and enhance existing production processes.
• Identify and supervise development of new products.
• Monitor the compounding process to ensure that procedures provide product quality of the highest standard.
• Monitor product and inventory levels.
• Participate in product trend analysis.
• Assist in investigations related to non-conformances.
• Assist in the implementation of corrective and preventive action plans.
• Assist with applications to regulatory bodies.
• Provide expertise and testimony of compounding operations as needed during regulatory inspections.
• Assist in the drafting and review of protocols designed for product development and/or validation.
Knowledge, Skills & Abilities:
• PharmD required; State of New Jersey license as a Pharmacist is required. Multiple state licenses preferred.
• Compounding experience required, USP797-800.
• Knowledge of PK Software, Opus ISM, QS/I PrimeCare, McKesson or other industry recognized software.
• Drug and general research skills.
• Workflow management – Knowledge of sterile and non-sterile compounding practices.
• Extensive knowledge of compounding tools and equipment.
• Knowledge of associated standards and operating procedures in relation to cGMP.
• Knowledge of 503B practices, aseptic processes (USP <797> & <800>) (gowning, garbing, gloving etc.)
• Computer experience (Microsoft Word, Excel, and Power Point).
• Clear communication skills.
• Specific expertise, skills and knowledge within research, development, and sterile compounding gained through education and experience.
• A broad perspective to organize objectives, both long-term and day-to-day activities.
• Take strategic objectives, accept accountability and drive results through effective actions.
• The ability to change direction and focus to meet shifting organizational and business demands.
• The ability to set clear targets and use performance measures to assess risk and opportunities.
• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage self, demonstrate integrity, be productive under pressure, and achieve development goals.
• The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.
• The ability to manage multiple resources and be accurate and current with data and information.
• The ability to create new products and processes that add value to the Business by applying creative and analytical approaches.
• Accepts feedback, asks questions, and delegates
• Builds and fosters professional relationships
Position Type and Expected Hours of Work
This is a full-time position in a 503B compounding pharmacy with regular operations occurring between Monday-Friday and various hours Saturday and Sunday depending on workload basis. Working hours may vary anywhere from several hours before opening to several hours after closing. Rotating shifts as well as holiday and work during inclement weather may be required.
Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
This pharmacy is a drug-free workplace. Completion of Pre-Employment Drug Screen is required before an offer of employment. In addition, employees in certain positions are subject to random drug testing.
Please note this job description does not cover or contain a comprehensive listing of all activities, duties or responsibilities that are required of the employee for this position Duties, responsibilities and activities may change at any time, with or without notice.
Healthcare Consultants Pharmacy Staffing has provided Direct Hire, Temp to Hire, and Per Diem/Temp pharmacy Staffing services in Florida and the Southeast United States for over 27 years now. Healthcare Consultants is a provider of Direct Hire pharmacy staffing services throughout the United States of America. With numerous positions available we encourage you to contact us online or call us at 800-642-1652 today!
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