We are looking for a Stability and Specification Coordinator who will be responsible for maintaining stability chambers, calendars, and a stability database.
Roles and Responsibilities:
- 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 managing ALL Retain samples for raw materials, domestic and international Finished products
- Responsible for managing and updating All sourcing, Raw materials, and Finished Products specifications
- Communicate effectively with other departments within the organization and function within a team environment.
- Perform other assigned duties as may be required in meeting company objectives
Minimum Requirements :
- Knowledge of current GMP regulations for laboratory and ICH guidelines for the stability area is a must. 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 viability of new product formulations on test. 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.
- Effective interpersonal, self-motivation skills, and the ability to interact with all levels of personnel are required. Knowledge of Data integrity violations in Quality Control Laboratory practices is desired.
- Experience with a database program such as Access (LIMS) and Excel is a must. Even though this is not a bench chemist position, understanding laboratory concepts and testing methodologies is critical.
Education and Experience:
- Position requires an Associate Degree or higher.
- 3-5 years' experience in stability program coordination or interpretation of stability data in pharmaceutical, nutraceutical, or medical device company will be considered.