Stability and Study Coordinator

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One of the nation's largest independent testing facilities is seeking a Stability and Study Coordinator with a minimum of 2 years of stability systems experience in a GMP environment. The ideal candidate will also have prior experience as an Analytical Chemist, testing products for the pharmaceutical, nutritional, cosmetic, personal care, medical device, or related industries. The position requires knowledge of testing products in a GMP-regulated facility, understanding client requirements, technical documentation, and the ability to prepare testing protocols.

Responsibilities include, but are not limited to :

• Communicating with clients regarding studies to ensure timely processing and submission to laboratories.
• Entering stability studies and related information into company software and coordinating testing schedules.
• Performing time point pulls within guidelines, documenting details as per SOPs, customer, and regulatory requirements.
• Submitting stability samples to appropriate departments.
• Developing and generating stability study protocols based on customer requirements, SOPs, and regulatory standards.
• Compiling raw data, verifying results, and generating reports.
• Preparing shelf life summary reports based on data analysis.
• Coordinating with management on workload and schedules.
• Preparing sample shipments and paperwork.
• Documenting work clearly and accurately, performing technical writing and peer reviews as needed.
• Working effectively in a fast-paced environment.

Education and Experience :

Physical Requirements and Working Conditions :

All qualified applicants will receive consideration without regard to sex, gender identity, sexual orientation, race, religion, national origin, disability, veteran status, age, or other protected characteristics.

Additional Details :

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