3rd Shift Quality Leader — Filling Operations

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Supervisor - Filling (3rd shift) to lead environmental monitoring and QALO oversight on the production floor. You will supervise QALO personnel, ensure regulatory compliance and drive quality initiatives across manufacturing operations.

The role focuses on safeguarding product quality, mentoring staff, and delivering timely investigations, deviations, and SOP documentation in a cGMP setting.

Qualifications

• Experience supervising quality operations in manufacturing environments.
• Strong ability to ensure regulatory compliance and cGMP adherence.
• Experience authoring and revising SOPs, batch records and related docs.
• Proven track record leading teams in high-stakes manufacturing settings.

Responsibilities

• Lead EM and QALO activities to ensure product quality and compliance.
• Hire, develop, and evaluate Quality staff, fostering continuous improvement.
• Provide rapid, quality-first decisions in collaboration with production.
• Ensure training and compliance of QALO associates and Quality Technicians.
• Author, revise, and review SOPs, batch records, and documentation as needed.

Skills

People management

Regulatory compliance

SOP development

Investigation handling

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Supervisor - Filling (3rd shift) to lead environmental monitoring and QALO oversight on the production floor. You will supervise QALO personnel, ensure regulatory compliance and drive quality initiatives across manufacturing operations.

The role focuses on safeguarding product quality, mentoring staff, and delivering timely investigations, deviations, and SOP documentation in a cGMP setting.