Quality Supervisor - GMP QA Lead (Weekend Shift)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Match

Paid Holidays

Paid Time Off

Parental Leave

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Supervisor to join the Quality Assurance Leadership Team. You will provide direct support to Environmental Monitoring, QALO and Manufacturing to ensure finished products meet specifications, supervising QALO personnel and ensuring regulatory compliance.

You will drive training, investigations, SOP development, and audit readiness, coordinating with cross-functional teams while upholding GDP, FDA regulations and Simtra quality

Qualifications

• Bachelor’s degree in a science discipline preferred.
• Minimum 2 years of leadership experience in a pharma/GXP setting.
• Working knowledge of FDA CFR 210,211 and GDP required.
• Experience with environmental monitoring preferred.
• Aseptic manufacturing knowledge is required.
• Proficiency with enterprise software (D365, Blue Mountain, Veeva, etc.).
• Strong technical, analytical and problem-solving abilities.

Responsibilities

• Lead QALO and environmental monitoring activities on the production floor.
• Provide rapid, quality-first decision-making with cross-functional teams.
• Ensure training and compliance of QALO associates and Quality Technicians.
• Author and approve investigations, deviations, and SOPs.
• Maintain audit-ready status and regulatory understanding across areas.
• Support continuous improvement initiatives and site metrics.

Skills

Leadership

Regulatory knowledge

GDP knowledge

Analytical skills

Problem-solving

MS Office

Education

Bachelor’s degree (preferred science)

Associate’s degree with 3+ years experience

Experience without degree (5+ years)

Tools

D365

Blue Mountain

Veeva

Microsoft Excel

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Supervisor to join the Quality Assurance Leadership Team. You will provide direct support to Environmental Monitoring, QALO and Manufacturing to ensure finished products meet specifications, supervising QALO personnel and ensuring regulatory compliance.

You will drive training, investigations, SOP development, and audit readiness, coordinating with cross-functional teams while upholding GDP, FDA regulations and Simtra quality