We are seeking a highly motivated individual to join our client's Analytical Development (AD) group. The individual will work with the AD team to oversee multiple stability programs and to manage internal sample inventory. The individual will work closely with members of the AD and Quality teams, as well as external organizations to manage stability testing schedules, data receipt and review, data integrity check, trending of stability results, and stability report authorship. To a lesser extent, the individual will also be responsible for sample inventory shipping, receiving and tracking.
- Manage internal stability programs in compliance to existing protocols.
- Author or amend stability protocols, and author interim and final stability reports.
- Work with Quality colleagues to ensure stability testing schedule, timely completion and reporting of results for a stability time point.
- Assist in authoring internal deviations that may arise from stability test
- Trend stability data to include in stability reports
- Perform data reviews of documents to ensure data traceability and accuracy of reports.
- Perform data integrity checks for stability reports and other documents.
- BA/BS or MS degree in Chemistry, Biochemistry, Biology or other related field with 2+ years of relevant experience
- Self-directed individual who can work with limited direction in a fast-paced environment
- Experience with GMP environment is desired but not required
- Strong organization, and communication skills with a positive attitude.
- Experience with statistical analysis tools such as JMP
- Experience with Electronic Laboratory Notebook system
- Excellent communication skills, oral and written