Stability Coordinator

Eurand is a specialty pharmaceutical company that develops, manufactures and commericalizes innovative pharmaceutical and biopharmaceutical products through the application of its advanced proprietary product development technologies.  With a command of four distinct platforms, Eurand has one of the broadest drug delivery offerings in the pharmaceutical industry.

 

Stability Coordinator:

The essential job function is to develop stability systems and controls for Eurand's stability program.  Receive stability samples, track and pull samples as required and insure testing and data generation. The position requires the ability to assess workload, stability demand and to support Operations, Research and Development, and Customers.

 

Major Responsibilities: Maintain the daily Stability Control systems, e.g. calibration, sample storage, and environmental chambers.Audit, check, and approve stability worksheets, original data, and laboratory notebooks.Assist in reviewing and approving stability documentation such as stability test methods and validation reports.Develop, implement, and monitor appropriate procedures and controls (SOP’s, test methods,and specifications).Assist with preparation, changes, writing and approval of stability “SOP’s” for Quality Control.Help assure the QC laboratory meets all stability related cGMP’s, ICH Guidelines, and customer requirements.Coordinate tasks and timelines for the Project Teams.Communicate risks, assumptions, and timing to management.Coordinate regulatory, compliance, and technical aspects of stability program.Investigate any significant stability deviations and/or trends in results, and report such deviations to Quality Control manager.Remain current on industry trends and regulatory guidances (FDA, ICH, etc.)Observe all safety procedures and regulations.Assist R&D as required during product scale-up and method development.Follow other job related instructions and perform other job related duties as requested.

Knowledge and Experience:B.S. degree in Chemistry, Biology or related physical sciences, with at least five (5) years experience in cGMP pharmaceutical environment. Understanding of compliance with US and Internal Regulatory requirements and understanding requirements for ICH Stability.Ability to work in a matrix team environment with a focus of meeting key customer needs is essential.Excellent communication, negotiation and influencing skills are required. Ability to work hard and contribute to a rapidly changing working environment.Pro actively achieve results for the best of the organization.Commitment to teamwork.Ability to focus attention to details and ensure high quality work.

Eurand offers competitive wages based on experience and education, comprehensive benefits, and excellent working conditions.

 

Successful candidate must pass a background check and drug screen.

 

Eurand is an equal opportunity employer!