Sr. QA Microbiology Specialist – Drug Substance
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Albany, NY, USA |
| Salary | $66400 – $148400 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree in Microbiology/Life Science field
- 2+ years of experience for QA Microbiology Specialist
- 5+ years of experience for Sr QA Microbiology Specialist
- 8+ years of experience for Principal QA Microbiology Specialist
- Basic knowledge of biopharmaceuticals and cell culture manufacturing
- Ability to enter and work in aseptic controlled environments
- Knowledge of current industry microbial aseptic practices
Responsibilities
- Lead and be a team member for microbiologically based initiatives
- Observe manufacturing operations to provide feedback for microbial controls
- Partner with training team to develop and deliver training solutions
- Aid in investigations pertaining to microbial controls
- Provide advice on technology transfer plans related to microbiological method transfers
- Review SOPs, microbiology assay validation, sterilization and related documentation
- Provide quality support of API manufacturing
- Assess the impact of deviation investigations and changes
- Review and provide input on environmental monitoring SOPs and validation
- Support the work of QA Microbiology, QC, and Manufacturing training groups
- Aid in quality audits of CMOs as the microbiology authority
Preferred Qualifications
- Excel in a quality driven organization