Quality Supervisor – GMP Manufacturing Leader

Simtra-Biopharma-Solutions; Bloomington (IN); Vor Ort; USD 90.000 - 125.000; Vollzeit

Benefits dieser Stelle

Medical & Dental Coverage

401(k) Retirement Savings Plan with 公司

Paid Holidays

Paid Time Off

Parental Leave

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Zusammenfassung

Simtra BioPharma Solutions in Bloomington, IN, seeks a Quality Supervisor to join the QA Leadership Team. You will supervise QALO personnel, oversee environmental monitoring, and ensure finished products meet specifications while complying with FDA and Simtra SOPs.

You will lead investigations, author procedures, and drive continuous improvement in a high‑quality manufacturing setting. Monday–Thursday first shift, with related scheduling.

Qualifikationen

• Bachelor’s degree in a science discipline preferred, with 2 years in pharmaceutical quality/manufacturing or GXP.
• Or an Associate’s degree with at least 3 years in the sector, or no degree with 5+ years in the sector.
• 2+ years of leadership in a regulated environment; familiarity with FDA CFR 210/211 and GDP.

Aufgaben

• Oversee Environmental Monitoring and QALO; supervise QA personnel on the production floor.
• Provide rapid, quality-first decision making with cross-functional teams.
• Author, revise and review SOPs, batch records and documentation to meet regulatory requirements.
• Lead audit readiness and drive continuous improvement initiatives.
• Ensure compliance with safety, regulatory and corporate standards.

Kenntnisse

Leadership

Regulatory knowledge

GXP experience

Problem solving

Communication

Technical writing

Ausbildung

Bachelor’s degree in science

Associate’s degree (alt path)

No degree with 5+ years experience

Tools

D365

Blue Mountain

Veeva

Microsoft Word

Excel

Outlook

Jobbeschreibung

Simtra BioPharma Solutions in Bloomington, IN, seeks a Quality Supervisor to join the QA Leadership Team. You will supervise QALO personnel, oversee environmental monitoring, and ensure finished products meet specifications while complying with FDA and Simtra SOPs.

You will lead investigations, author procedures, and drive continuous improvement in a high‑quality manufacturing setting. Monday–Thursday first shift, with related scheduling.