Aseptic GMP Manufacturing Lead

PCI TRGR Penn Pharmaceutical Services Ltd; Madison (WI); Presencial; USD 85 000 - 120 000; Tempo integral

Resumo da oferta

PCI Pharma Services in the United States is seeking a Manufacturing Supervisor to lead an aseptic and medical device manufacturing team, ensure execution of production plans across multiple shifts, and maintain compliance with cGMP and FDA regulations.

You will coach staff, manage safety, drive continuous improvement, and partner with cross-functional teams to optimize operations while meeting quality metrics and regulatory expectations.

Qualificações

• Minimum High School Diploma or equivalent.
• 5-7 years of experience in GMP environments.
• 3-5 years of leadership or supervisory experience.
• Experience with GMP, FDA and other regulated environments.
• Able to make real-time decisions on safety, process, scheduling.
• Strong prioritization and resource management in production.

Responsabilidades

• Ensure safety of manufacturing areas and adherence to PCI HSE programs.
• Motivate and coach teams to drive high performance.
• Supervise cGMP operations to meet scheduled production work.
• Plan and execute equipment prep and fill activities per GMP.
• Collaborate to optimize processes with other supervisors.
• Recruit and manage staff and ensure resource utilization.
• Provide leadership aligned with cGMP and quality standards.
• Identify and mitigate operational risks and escalate as needed.
• Establish KPIs and report metrics for the area.
• Work with training to implement department training plans.
• Ensure training materials are accurate and detailed.
• Ensure timely investigations, deviations and CAPAs.
• Use quality metrics to drive team performance.
• Support real-time batch review and Right First Time.
• Maintain inspection readiness in assigned areas.
• Participate in client and regulator inspections.
• Identify continuous improvement opportunities.

Conhecimentos

Leadership

GMP

FDA compliance

Team building

Quality metrics

Training & coaching

Risk management

Formação académica

High School Diploma

Ferramentas

GMP training software

Descrição da oferta de emprego

PCI Pharma Services in the United States is seeking a Manufacturing Supervisor to lead an aseptic and medical device manufacturing team, ensure execution of production plans across multiple shifts, and maintain compliance with cGMP and FDA regulations.

You will coach staff, manage safety, drive continuous improvement, and partner with cross-functional teams to optimize operations while meeting quality metrics and regulatory expectations.