Pharma Quality Leader - On-Floor Ops & Compliance

Codis; Seymour (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Codis in Seymour, Indiana is seeking a seasoned Quality Supervisor to lead the site Quality team and partner with Manufacturing to ensure products meet regulatory, customer, and company standards. The role focuses on hands-on floor leadership, batch review and release, CAPA investigations, and continuous improvement of Quality systems while coaching staff and driving cGMP compliance on a day-to-day basis.

You will monitor metrics, support regulatory inspections and supplier audits, and ensure

Qualifications

• Bachelor's degree in Applied Science, Engineering, Quality Management, or related field.
• Minimum 5 years of progressive Quality Assurance experience in regulated manufacturing.
• Previous supervisory or senior-level Quality Assurance experience.
• Strong knowledge of cGMPs and regulatory requirements.
• Experience with deviations, investigations, CAPA, change control, complaints, and document control.

Responsibilities

• Lead and develop Quality team members on the production floor.
• Provide hands-on Quality support to manufacturing operations.
• Support batch review and release activities and ensure timely review.
• Oversee Quality inspection, laboratory, and release activities.
• Coordinate investigations involving deviations, nonconformances, complaints, SCARs.
• Lead root cause analysis and CAPA development.
• Track investigations, CAPAs, change controls, and quality metrics.
• Identify opportunities to improve Quality systems and processes.
• Support regulatory inspections and supplier/vendor audits.

Skills

Leadership

Root cause analysis

Communication

Documentation

Problem solving

Risk assessment

Quality systems

Education

Bachelor's degree in Applied Science, Engineering, Quality Management, or related field

Job description

Codis in Seymour, Indiana is seeking a seasoned Quality Supervisor to lead the site Quality team and partner with Manufacturing to ensure products meet regulatory, customer, and company standards. The role focuses on hands-on floor leadership, batch review and release, CAPA investigations, and continuous improvement of Quality systems while coaching staff and driving cGMP compliance on a day-to-day basis.

You will monitor metrics, support regulatory inspections and supplier audits, and ensure