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Summary of Position
The Production Supervisor is responsible for the oversight of manufacturing operations associated with the manufacturing of radiopharmaceuticals, which meet approved specifications by supervising from the floor, coaching and developing their team, and ensuring that their area of operations maintains compliance with Corporate policies, local and federal regulations. The Supervisor is responsible for fostering a culture of team ownership, transparency, and team success.
Essential Functions
- Ensure proper coverage of all production while also managing team PTO, trainings, absences, and other events impacting staffing.
- 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 area 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 comply with all policies, procedures, and site/company regulations.
- Set a 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 troubleshooting.
- 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.
- Lead and/or support all investigations, manufacturing exceptions, product failures, Root Cause Analyses, 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 the area.
- Manage the department’s overtime and ensure that all payroll exception reports are completed and submitted on time.
- Lead team in continuous improvement activities and take control when faced with adversity while incorporating team input.
- Measure and communicate the team’s progress against individual, team, site goals, and KPIs.
- Communicates issues appropriately, utilizing the area’s escalation plan.
- Spend 70% of your time on the production floor directly with employees and processes.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Ensure all direct reports are properly trained in areas directly related to their job responsibilities as well as company policies, quality policies, and safety/environmental policies.
- Conduct Production Team meetings as well as 1-on-1 coaching sessions with employees in the department.
Requirements
- Bachelor of Science degree in Manufacturing, Engineering, or related field required. Work experience is considered in lieu of a degree.
- Ten or more years of relevant work experience required, including experience in a cGMP environment, preferably in manufacturing.
- Two or more years of supervisory experience is required.
- 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 and/or terminal sterilization processing experience preferred.
- Prior experience leading projects and/or being a core team member preferred.
