Quality Supervisor – GMP Quality Leader (Fri–Mon Shift)

Simtra US LLC; Bloomington (IN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Plan with Company Match

Paid Holidays

Paid Time Off

Parental Leave

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Vision Coverage

Job summary

Simtra BioPharma Solutions is seeking a Quality Supervisor to join the Quality Assurance Leadership Team in Bloomington, IN. You will supervise QALO personnel, ensure finished products meet specs, and support manufacturing with regulatory compliance on the production floor.

Reporting to the Quality Manager, you will drive daily QA operations, lead investigations, and guide cross-functional teams to sustain high-quality outcomes and patient safety. Weekend/evening shifts and OT may be required.

Qualifications

• Bachelor's degree (preferred science discipline) with 2+ years in Pharmaceutical Quality/Manufacturing or 3+ years with an Associate's degree, or 5+ years without a degree in GXP.
• Minimum 2 years of leadership experience.
• Working knowledge of FDA CFR 210,211 and GDP required.
• Knowledge of aseptic manufacturing processes is required.
• Strong interpersonal/communication/influencing/negotiation skills.
• Proficient in Microsoft Word, Excel, and Outlook; able to use enterprise software (e.g., D365, Veeva).
• Strong technical, analytical, and problem-solving skills.

Responsibilities

• Perform primary responsibilities of QALO personnel.
• Grow and manage QALO personnel including hiring and evaluating performance.
• Provide rapid, quality-first decision-making with manufacturing and cross-functional teams.
• Ensure training and compliance of QALO associates and QA Technicians.
• Author and approve investigation/deviation reports.
• Lead ongoing QALO activities and assist cross-functional areas for successful execution.
• Ensure tasks are completed to meet quality and site metrics.
• Draft, revise, and review SOPs, batch records, and docs to meet regulatory requirements while supporting CI initiatives.
• Ensure compliance with all regulations related to quality and employee safety.
• Lead multiple process/product improvement projects and data generation.
• Maintain audit-ready status and understand regulatory/SOP requirements.

Skills

Leadership

Quality systems

GXP regulations

GDP

CFR 210/211

Problem-solving

Communication

Education

Bachelor's degree in science

Tools

Microsoft Word

Excel

Outlook

D365

Veeva

Job description

Simtra BioPharma Solutions is seeking a Quality Supervisor to join the Quality Assurance Leadership Team in Bloomington, IN. You will supervise QALO personnel, ensure finished products meet specs, and support manufacturing with regulatory compliance on the production floor.

Reporting to the Quality Manager, you will drive daily QA operations, lead investigations, and guide cross-functional teams to sustain high-quality outcomes and patient safety. Weekend/evening shifts and OT may be required.