A Supervisor of Production is responsible for ensuring accountability, transparency, and effective communication cross-functionally and within his/her team while ensuring information is timely, clear and accurate. By coaching and developing his/her team to High Performance, he/she will foster a culture of team ownership that ensures compliance with all Corporate and Local policies, procedures and regulations.
While supervising in a cGMP environment, he/she must maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, NRC, BDB, DHSS, etc.) In addition, he/she must supply the highest level of both internal and external customer service. To effectively recognize and reward performance, the supervisor must measure and communicate the team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).
The Supervisor is responsible for supervising the operations associated with the manufacturing of a radioactive drug product which meets site specifications by supervising from the floor in the areas of clean up, set up and operation of equipment by trained and qualified personnel. Areas of operation to include: formulation, dispensing, packaging, and release of final drug product. This position is also responsible for support activities such as maintenance and disinfection.
This shift will normally cover four days a week. Normal hours covered by this position are 5:30 PM – 4:00 AM Saturday through Tuesday each day with overtime as required to ensure timely release of products. Normal workdays will be Saturday, Sunday, Monday, and Tuesday.
- Ensure proper coverage of production in DTE/I123/maintenance and to support Quality System and process improvements.
- This supervisor will cover processes on the night shift in DTE/ I123/disinfection/maintenance.
- Ensure accountability, transparency, and effective communication cross-functionally and within the team while guaranteeing information is timely, clear and accurate.
- Review and approve weekly departmental schedules and maintenance activities; work with multiple departments to ensure efficient scheduling and planning in order to meet the production plans.
- Ensure appropriate communication on production and project related matters with Management in a timely manner.
- Coach and develop the team to High Performance while fostering a culture of team ownership.
- Verify, review and make appropriate changes if needed, to any controlled document pertinent to your area of responsibility.
- Ensure all employees compliance with all policies, procedures and site/company regulations.
- Set clear vision by ensuring goals and objectives are aligned with site strategies through performance management for each team member.
- Exhibit accountability and responsibility for an area or process in order to affect change and lead efforts and ideas to completion.
- Provide input on equipment installation, start-up operation and trouble shooting.
- Provide leadership for employee relations through effective communications, coaching, training and development; eliminate roadblocks in order for the team to move forward.
- Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
- Understand and provide education and feedback to team regarding business and financial impact of decisions/actions.
- Lead and/or support all investigations, manufacturing exceptions, product failures, RCA and customer complaints at the appropriate level with complete and comprehensive detail.
- Author, approve and/or review all area quality and safety exceptions and investigation reports. Ensure on time completion of all corrective action items assigned to area.
- Ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.
- Manage the department’s overtime (OT) and ensure that all exception reports are completed and submitted on time to Payroll bi-weekly.
- Lead team in continuous improvement activities and take control when faced with adversity while incorporating team input.
- Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).
- Complete and maintain the RHP Production supervisor OJT qualifications.
- Communicates issues appropriately utilizing the area’s escalation plan.
- Spend 70% of your time on the floor directly with employees and processes.
- Bachelor’s Degree in Science or Engineering related field preferred.
- 5 years of experience in a cGMP environment required, preferably in manufacturing.
- Minimum of 3 years in a Supervisory role.
- Lean/Kaizen/Six Sigma experience preferred.
- Experience working with High Performance Teams
- Coaching & Implementing Autonomous Maintenance activities preferred.
- Experience with developing/documenting procedures required.
- Aseptic processing experience preferred.
- Knowledge of radioactive material handling and contamination control preferred.