Quality Analyst II - Batch Record Review and Release
Simtra BioPharma Solutions(3 days ago)
About this role
Simtra BioPharma Solutions specializes in cGMP manufacturing of biologics, small molecules, and vaccines, with a focus on quality, regulatory compliance, and supporting clients in scaling and innovating life-changing medicines. The company provides manufacturing, formulation, and regulatory support across facilities in Indiana and Germany.
Required Skills
- GMP
- Batch Review
- Quality Assurance
- Regulatory Compliance
- Documentation
- Troubleshooting
- Audit
- Sterility Assurance
- Veeva
- Microsoft D365
About Simtra BioPharma Solutions
simtra.comSimtra 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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