Production Supervising Pharmacist

Pentec Health   •  

Boothwyn, PA

Not Specified years

Posted 240 days ago

This job is no longer available.

Objective:

Provide operational, supervisory, and leadership to the production team members within an FDA registered outsourcing facility.  Possesses knowledge of USP <797> and cGMP regulations and has experience with production of compounded sterile preparations (CSPs) ensuring compliance with all federal and state regulatory requirements for an outsourcing facility. 

 

Essential Duties & Responsibilities:

  • Directly supervise all personnel and functions involved in the production of CSP and manages the day to day cleanroom activity, as well as, providing technical support to production team members. 

·         Oversee and participate in the operation of the production areas specific to compounding/cleanroom facility, sterile intravenous preparations, and outsourcing operations, including all compliance activities under the Quality program. 

  • Works closely with Quality and Operations to ensure all production efforts are in compliance with cGMP and trains staff accordingly.

·         Participates in the selection, training, professional growth and development, and supervision, inclusive of performance evaluations in accordance with HR policy for all directly reporting production personnel. 

  • Assists in the development, training and adherence to all Pentec policies and procedures in compliance with USP <797> and cGMP expectations and assures the production department is performing consistently within all organization standard operating procedures (SOPs).

·         Works within a team environment to implement and maintain a distribution and compounding model that ensures operational efficiencies and automation in place to support new business and promote maximum safety and service to our customers.

·         Strong focus for training of staff, attention to detail and documentation – both for compliance and regulatory – for facility environment (cleaning, disinfection and maintenance) and personnel.  Coordinates the pharmacy production team utilizing existing and potentially new information systems, including automation and/or robotics, to ensure appropriate flow of information from the production area, including the change parts washroom and labeling responsibilities to other departments within the outsourcing facility.

·         Assures that all CSPs are distributed in accordance with federal, state and local laws in accordance to standards of practice including all regulatory and accreditation requirements.

·         Implement and maintain systems to ensure the safe, accurate, aseptic preparation of all CSPs and processes – this includes participation in the IOQ and PQ of any piece of equipment, in conjunction with the validation team. 

·         Implements work schedules, assignments, and benchmarks to maximize operational efficiency and staff productivity, while minimizing overtime.

·         Interacts effectively with Operations, Distribution, Quality and Purchasing team members, company leaders, and Human Resource staff.

·         Actively involved in the evaluation and selection of new products and equipment to increase staff productivity and ensure quality and safety in clean room compounding practices.                                                                                                                                                              

·         Serves as a company representative as requested in the clinical and business communities.

·         Assists in Root Cause Analysis in regard to test failures and process failures.

·         Contributes to the enhancement of teaching protocols and manuals for the education and development of pharmacy staff.

·         Applies for, completes all required testing, and obtains pharmacy licensure in other states as business needs arise.

·         Performs other duties, special projects as assigned.

Authority & Accountability

  • Member of the 503B Leadership Team.
  • Responsible for managing and leading the production staff in an FDA registered outsourcing facility.

 

Skills, Competencies and Experience:

 

Required

·         Strong leadership skills and experience;  supervisory or staff management abilities

·         Strong tactical implementation skills

·         Excellent oral and written communication skills

Preferred

  • Strong pharmaceutical background
  • cGMP experience in a related industry

Education, Certifications, Trainings:

 

Required

·         Supervisory experience in sterile compounding within a pharmacy or cGMP pharmaceutical environment. Licensure in good standing to practice pharmacy in the Commonwealth of Pennsylvania

·         BS in Pharmacy or Pharm. D. from an accredited school of Pharmacy

Preferred

·         Advanced degree

·         Six Sigma Certification

Equipment:

Required

·         Proficiency in the following: MS Word and Excel

Preferred

·         Proficiency in Microsoft Dynamic AX ERP or similar software

·         Knowledge and experience with pharmacy automation, intravenous compounders and/or robotics

Req # 2251