Snr Quality Assurance Specialist
Edison-New Brunswick Metro Area, NJ
- Responsible for establishing microbiological policy requirements, and processes for compounds in development.
- Responsible for providing SME oversight and expertise associated with microbiological aspects in testing, manufacturing operations and deviation/investigation resolution for all company products.
- Is the main contact for regulatory agency inspections (FDA, EMEA, MHRA, etc.) associated with microbiological inquiries for compounds in development.
- Must be a technical/scientific expert in microbiology as it relates to pharmaceuticals. Must be able to measure technical/scientific attributes in qualitative ways and drive science-based decisions across the organization.
- 5-8 years of experience in biological/small molecule product quality assurance and/or manufacturing, with working knowledge microbiology, and virology techniques
- Thorough knowledge of cGMP in the pharmaceutical and biologics industries.
- Bachelors, Masters, or Ph.D. (higher degree preferred) in a microbiological science. 5+ (Ph.D.), 8+ (Masters) or 10+ (Bachelors) years of experience in microbiology for compounds in development.
- Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time.
- Minimal supervision and ability to contribute in a team environment. Able to communicate results and issues effectively, both written and orally. Knowledgeable in Microsoft Office, with an emphasis in MS Word and Excel.