Supervisor, Manufacturing Mon to Fri 3PM to 11:30 PM

PCI Pharma Services•Madison, WI

1d•Onsite

About The Position

The Manufacturing Supervisor leads a manufacturing team in a variety of complex tasks in accordance with the FDA and other regulatory agencies while following all safety guidelines of PCI. They will be responsible for supervising an aseptic and medical device manufacturing team (ex. equipment preparation, filling and Lyophilization activities). Ensure execution of production plans across multiple shifts and manage staff performance against department’s operational goals.

Requirements

Minimum High School Diploma
5-7 years of experience in a GMPs environment required
Experienced in making real time decisions on safety, process, scheduling and personnel-related issues.
Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs.
Proven leadership, persuasiveness, initiative, and problem solving skills.

Nice To Haves

3-5 years of experience leading direct reports or teams is preferred
Experience with GMPs, FDA and other regulated agency environments is required

Responsibilities

Ensure safety of manufacturing area and work practices in accordance with all PCI Health, Safety and Environmental program.
Be highly visible, hands-on team builder to motivate, coach, support, inspire and retain highly effective teams while managing for high performance and developing others.
Coordinate and supervise Manufacturing personnel in the cGMP operations to meet all scheduled manufacturing work.
Partner with Planning to ensure effective prioritization and schedule adherence and to meet all required capacity demands.
Guide and train employees to ensure FDA and other regulatory agency requirements have been properly implemented and are continually met.
Plan and execute manufacturing instructions in order to perform equipment preparation, and fill activities for aseptic and non-aseptic products in accordance with Good Manufacturing Practices (GMP).
Collaborate with the other supervisors and enabling groups to optimize processes.
Recruit and supervise staff to execute department functions; ensure effective utilization of resources through consistent performance management.
Provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards.
Proactively identifies, assesses, and mitigates operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams.
Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics.
Collaborate with training to design department training plan and training plan execution. Ensure Training materials are accurate and sufficiently detailed.
Ensure Timely completion of investigations, deviations and CAPAs.
Utilize quality metrics to measure, analyze, and improve team performance.
Ensure Real time batch review and "Right First Time".
Ensure Inspection readiness of assigned manufacturing areas.
Participates in inspections conducted by external clients and regulators.
Identifies continuous improvement opportunities to improve processes and practices.