Quality Supervisor (Pharmaceutical Manufacturing)

Codis

Seymour (IN)

On-site

USD 70,000 - 100,000

Full time

8 days ago
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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

Quality Supervisor

Location: Seymour, Indiana

Codis is seeking an experienced Quality Supervisor to join our Quality team at our Seymour, Indiana manufacturing facility. This is a hands-on leadership opportunity for a Quality professional who enjoys being close to manufacturing operations, developing employees, solving problems, and ensuring products consistently meet regulatory, customer, and company requirements.

The Quality Supervisor provides day-to-day leadership and oversight for Quality activities at the Seymour site, including floor support, batch review and release, Quality inspections, laboratory activities, document control, investigations, CAPA, change control, and other Quality systems.

This position works closely with Manufacturing and other departments and serves as an important link between the Quality team, site leadership, and the Quality Director.

What You'll Do
  • Lead, coach, and develop Quality team members, including Quality Assurance Technicians, Auditors, Document Control Specialists, and Laboratory Technicians.
  • Provide hands-on Quality support to manufacturing operations and serve as a visible Quality presence on the production floor.
  • Support batch review and release activities and ensure raw materials and finished products are reviewed and released within established timelines.
  • Oversee Quality inspection, laboratory, and release activities.
  • Coordinate investigations involving deviations, nonconformances, customer complaints, Supplier Corrective Action Reports (SCARs), and other Quality-related issues.
  • Lead and support root cause analysis and the development of effective corrective and preventive actions (CAPAs).
  • Track and trend investigations, CAPAs, change controls, complaints, and other Quality system activities.
  • Identify opportunities to continuously improve site Quality systems and processes.
  • Support Annual Product Review (APR) activities and ensure assigned activities are completed according to schedule.
  • Monitor Quality metrics and prepare information for management review.
  • Support regulatory inspections, customer audits, supplier/vendor audits, and contract manufacturer audits.
  • Ensure Quality documents and records are properly controlled and retained.
  • Review and improve site procedures to maintain compliance and operational effectiveness.
  • Partner with Manufacturing and other departments to resolve Quality issues while maintaining appropriate cGMP and Quality standards.
  • Provide ongoing coaching, performance feedback, and development opportunities for Quality team members.
What We're Looking For
  • Bachelor's degree in Applied Science, Engineering, Quality Management, or a related scientific or technical field.
  • Minimum of 5 years of progressive Quality Assurance experience within pharmaceutical manufacturing or another highly regulated manufacturing environment.
  • Previous supervisory, leadership, or senior-level Quality Assurance experience.
  • Strong knowledge of current Good Manufacturing Practices (cGMPs) and applicable regulatory requirements.
  • Experience with Quality systems such as deviations, investigations, CAPA, change control, complaints, supplier quality, document control, and material/product release.
  • Strong root cause analysis, risk assessment, and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Strong technical writing and documentation skills.
  • Ability to manage multiple priorities in a fast-paced manufacturing environment while maintaining accuracy and attention to detail.
  • Pharmaceutical solid-dose manufacturing experience is preferred.
The Right Fit

We're looking for someone who can be both a Quality leader and a collaborative business partner. You'll need to be comfortable making sound Quality decisions, coaching employees, working directly with Manufacturing, and stepping onto the production floor when an issue needs attention.

The ideal candidate understands that a strong Quality organization isn't simply about identifying problems. It's about preventing them, solving them effectively when they occur, developing strong systems, and helping teams consistently do things the right way.

If you have a strong Quality background, enjoy leading people, and want an opportunity to make a meaningful impact within a growing manufacturing organization, we'd like to hear from you.

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