Roles and Responsibilities:
- Maintains stability chambers.
- Maintains stability calendars and stability database.
- Composes stability protocols. Pulls stability samples at the appropriate dates.
- Maintains accurate records of stability samples. Coordinates stability testing activities and stability results. Writes stability summaries and stability reports.
- Assists with stability sample testing as needed. Makes conclusions about the data and trends when necessary.
- The stability coordinator is also responsible for maintaining the laboratory and warehouse temperature and humidity logging system.
- Communicates with product development regarding the status of new formula and new products on stability.
- Responsible for administration of the Special Request Program. Receives and logs in samples using LIMS system. Provides technical support to lab personnel regarding target sample weights used in testing actives ingredients.
- Coordinates in-house testing of Special Request samples and provides feedback and follow-up of Contract Lab testing. Requests raw data from contract labs when needed.
- Perform other assigned duties as may be required in meeting company objectives.
- Communicate effectively with other departments within the organization and function within a team environment.
Minimum Requirements : Knowledge of current GMP regulations for laboratory and ICH guidelines for the stability area is a must. Must have good writing skills and be detail oriented. Understanding scientific data and the interpretation of data is a must in order to discern trends and make calls about product stability/shelf life and to determine and to determine viability of new product formulations on test. Must be a self-starter and be motivated to ask questions regarding formulations and be a true owner of the process and the data that is collected. Must be able to troubleshoot and work out problems in testing such as comparison of methods, out of specification (OOS) results and out of trend (OOT) data. Experience with a database program such as Access and Excel is a must. Hands on laboratory experience are a must as well even though this position will not be a bench chemist. Understanding laboratory concept and testing methodologies is critical.
Education and Experience: 3-5 years’ experience in stability program coordination or interpretation of stability data in pharmaceutical, nutraceutical, or medical device company necessary.