Quality Assurance Supervisor – Lead QALO & EM

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) with Company Match

Paid Holidays

Paid Time Off

Education Assistance

Employee Ownership Plan

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Supervisor to lead QA functions on the production floor and ensure regulatory compliance for finished products. This role reports to the Senior Manager, Quality and oversees QALO personnel to uphold SISPQ standards.

The position requires a science degree with 2+ years in pharma QA/manufacturing or equivalent, plus leadership experience. Weekend AM shifts are part of the schedule and a strong emphasis on cross-functional collaboration

Qualifications

• Bachelor’s degree (preferred science discipline) with 2+ years in pharmaceutical QA/manufacturing or an equivalent combination; leadership experience preferred.
• Experience with GDP, aseptic processes, and regulatory compliance.
• Knowledge of FDA CFR 210,211 and Good Documentation Practices required.

Responsibilities

• Support EM, QALO and Manufacturing to ensure finished products meet specs.
• Lead and develop QALO personnel, including hiring and performance evaluation.
• Author and review SOPs, batch records, and investigations as needed.

Skills

Leadership

GDP knowledge

Environmental monitoring

Aseptic manufacturing

CFR 210/211

Office software

Education

Bachelor’s degree (preferred science discipline)

Associate’s degree

No degree with 5+ years experience

Tools

D365

Blue Mountain

Veeva

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Supervisor to lead QA functions on the production floor and ensure regulatory compliance for finished products. This role reports to the Senior Manager, Quality and oversees QALO personnel to uphold SISPQ standards.

The position requires a science degree with 2+ years in pharma QA/manufacturing or equivalent, plus leadership experience. Weekend AM shifts are part of the schedule and a strong emphasis on cross-functional collaboration