Simtra BioPharma Solutions is seeking a Science and Compliance Specialist to provide technical guidance in aseptic practices and compliance within their pharmaceutical manufacturing environment. The role involves leading investigations, drafting SOPs, and collaborating with teams to enhance operational performance
Job Summary
The Science and Compliance Specialist serves as an operations SME, providing technical guidance on aseptic practices and equipment, drafting and revising SOPs and controlled documents, and supporting production teams through troubleshooting, process optimization, and documentation accuracy.
The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment, applying structured problem-solving methods to identify root causes, maintain accurate cGMP compliant records, and drive effective CAPA implementation.
In return, you’ll be eligible for Day One Benefits including Medical & Dental Coverage, 401(k) Retirement Savings Plan with Company Match, and Time Off Program.
Matching Summary
Match Score: 85
Simtra BioPharma Solutions is seeking a Science and Compliance Specialist to provide technical guidance in aseptic practices and compliance within their pharmaceutical manufacturing environment. The role involves leading investigations, drafting SOPs, and collaborating with teams to enhance operational performance.
Skills & Requirements
Must-have
technical guidance on aseptic practices
drafting and revising SOPs
end to end investigations for deviations
structured problem-solving methods
cGMP compliant records
CAPA implementation
operational data analysis
process optimization
Nice-to-have
growth mindset
team collaboration
high standard of excellence
impact on patient health
Key Requirements
BS degree or equivalent aseptic pharmaceutical manufacturing experience
2+ years technical writing experience
Knowledge of GMPs and worldwide regulatory agency guidelines
Knowledge of applicable CAPA procedures
Microsoft Office Suite intermediate proficiency
Ability to utilize enterprise software systems (Veeva)