QC Microbiology & Stability Scientist
On-siteLedgewood, New Jersey, United States
Job Summary
Conduct routine and non-routine microbiological testing, including environmental monitoring, bioburden, microbial limits, endotoxin, and sterility testing. Manage stability program activities by coordinating studies, maintaining protocols and schedules, tracking time points, and entering data into stability software. Prepare and maintain laboratory documentation, including SOPs, protocols, and reports, while ensuring adherence to GMP, FDA, and ICH guidelines. Assist with QC samples for raw materials, finished drug products, and stability submissions to external laboratories. Investigate out-of-specification and out-of-trend deviations and support method validation. Review microbiological and stability data to ensure accuracy and compliance with regulatory requirements.
Required Qualifications
- Bachelor's Degree in scientific discipline
- 5 years of pharmaceutical laboratory environment experience
- equivalent combination of education and experience
- detail oriented
- well organized
- ability to work on multiple different tasks within a workday
- positive teamwork attitude
- Excellent interpersonal, oral, and written communication skills
- Maintains confidentiality of sensitive information
- Ability to meet attendance standards
- minimum of 40 hours in a week
- ability to work additional hours to accomplish the required tasks to meet deadlines
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