Quality Analyst Lead- Batch Review

Simtra BioPharma Solutions(3 days ago)

United States, Bloomington, IndianaOnsiteFull TimeSenior$70,000 - $90,000Quality Assurance

About this role

Simtra BioPharma Solutions is a Contract Development and Manufacturing Organization specializing in sterile injectable products for pharmaceutical and biotech companies. The company emphasizes quality, regulatory compliance, and supporting clients from formulation to commercialization, with a focus on biologics, small molecules, and vaccines.

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Required Skills

Quality Assurance
Batch Records
GMP
Documentation
Regulatory Compliance
SOP
ARO
Analysis
Root Cause
Process Improvement

Qualifications

Bachelor's degree in a science discipline
2 years experience in Pharmaceutical Quality or Manufacturing
Knowledge of aseptic manufacturing processes

About Simtra BioPharma Solutions

simtra.com

Simtra BioPharma Solutions is a contract development and manufacturing organization (CDMO) focused on sterile injectable products. They offer end-to-end services — from formulation and analytical development through aseptic fill/finish, packaging, quality and regulatory support — to advance programs from clinical stages to commercial supply. Simtra emphasizes flexible product delivery options and a compliance-driven approach to meet biopharma partners’ timelines and manufacturing requirements.

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