Quality Supervisor, Filling — 3rd Shift Leader

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a Quality Supervisor for the Filling line on the 3rd shift. You will lead Environmental Monitoring, QALO and Manufacturing quality oversight, supervise QALO personnel, and ensure finished products meet specifications while upholding Simtra SOPs.

This role requires strong decision-making, training and development of staff, investigation/deviation handling, and leading audits.

Qualifications

• Experience leading QA/production teams in pharmaceutical manufacturing.
• Knowledge of cGMP, regulatory guidance and SOPs.
• Ability to author, review and approve investigations and deviation reports.
• Strong collaboration with manufacturing and cross-functional teams.”

Responsibilities

• Able to perform EM and QALO responsibilities on the floor.
• Grow, manage, and evaluate QA personnel and contractors.
• Provide rapid, quality-first decisions with manufacturing teams.
• Ensure training and regulatory compliance of QALO staff.
• Author and approve investigation/deviation reports.
• Lead daily QALO and environmental monitoring activities.
• Ensure tasks are completed to meet quality and site metrics.
• Maintain and improve SOPs and batch records with regulatory alignment.
• Ensure compliance with all regulations affecting product quality and safety.
• Lead audits readiness and support regulatory requirements.

Skills

People management

Quality Assurance

Regulatory compliance

Investigations & CAPA

Job description

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a Quality Supervisor for the Filling line on the 3rd shift. You will lead Environmental Monitoring, QALO and Manufacturing quality oversight, supervise QALO personnel, and ensure finished products meet specifications while upholding Simtra SOPs.

This role requires strong decision-making, training and development of staff, investigation/deviation handling, and leading audits.