Night-Shift Quality Supervisor: Fill/EM Leader

Simtra US LLC; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Day One Benefits

401(k) Retirement with Company Match

Time Off Program

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions is seeking a Quality Supervisor in Bloomington, IN to support Environmental Monitoring, QALO and Manufacturing. You will supervise QALO staff, drive quality on the production floor, and ensure compliance with regulatory standards and Simtra SOPs.

The role requires leadership experience, knowledge of GMP/GDP, and the ability to lead audits and process improvements. Third shift hours are included, with extensive benefits and a strong quality culture.

Qualifications

• Bachelor's degree in a science discipline or equivalent experience.
• 2+ years of leadership in pharma quality/manufacturing or 3+ years with an Associate degree.
• 5+ years pharma quality/manufacturing or related GXP experience without a degree.

Responsibilities

• Lead EM and QALO activities to ensure product quality and regulatory compliance.
• Provide training, performance evaluation and personnel development.
• Make rapid, quality-first decisions with cross-functional teams.
• Author and review SOPs, batch records, investigations and deviations.
• Maintain audit readiness and ensure adherence to FDA CFR 210, 211 and GDP.

Skills

Leadership

Communication

Regulatory knowledge

Problem solving

Quality systems

Education

Bachelor's degree in a science field

2+ years pharma quality/manufacturing or 3+ years with Associate degree

5+ years pharma quality/manufacturing without degree

Tools

Microsoft Word/Excel/Outlook

D365

Blue Mountain

Veeva

Job description

Simtra BioPharma Solutions is seeking a Quality Supervisor in Bloomington, IN to support Environmental Monitoring, QALO and Manufacturing. You will supervise QALO staff, drive quality on the production floor, and ensure compliance with regulatory standards and Simtra SOPs.

The role requires leadership experience, knowledge of GMP/GDP, and the ability to lead audits and process improvements. Third shift hours are included, with extensive benefits and a strong quality culture.