Stability Analyst III
An exciting opportunity to work with a progressive company that exemplifies dedication to innovation in the pharmaceutical industry. Seeking a Stability Analyst III to join a growing team!
Schedule: Mon-Fri 8:00am-5:00pm
Job Type: Direct Hire
The Stability Analyst III will be responsible for assisting in the management of the company’s stability ongoing commercial stability program.
- Maintain ongoing commercial stability program and assist with registration, clinical, and development stability studies.
- Review raw and final commercial stability data to ensure complete and proper documentation according to applicable procedures and cGMPs
- Enter and review stability data tables.
- Collaborate in OOS investigations or OOT investigations for stability studies
- Ensuring that all chemical and microbiology tests associated with drug product stability studies are completed per approved SOPs
- Assist with leachable testing
- Oversee the initiate / terminate studies, and disposal processes.
- Ensure that new studies have been properly labeled, stored in the appropriate conditions and orientation.
- Valid Driver’s license and able to travel between locations (w/in 1 mile)
- Bachelor of Science in Chemistry or related field
- 3 years of analytical experience in GMP lab or research setting
- 2 years of stability experience with testing and specifications
- 2 years of experience in stability programs
- Writing experience in SOP and technical reports
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!