Stability Coordinator – Remote
|Reports To||Compliance and Customer Quality Manager|
The Stability Coordinator will develop, implement, and lead the product stability process for appropriate products that are manufactured and/or distributed from the GGUI US and Ireland facilities. This role is responsible for the development, review, and approval of stability protocols and stability reports, and management of the associated data. This role will effectively collaborate with appropriate departments and 3rd party vendors to ensure stability protocols are executed. This role will review analytical data generated during stability studies. This role is remote with required travel to Connecticut, Kentucky, and Ireland sites as appropriate.
|Duties & Responsibilities|
The Stability Coordinator will:
- Ensure compliance of the stability program to internal procedures and appropriate regulatory requirements. Design and generate stability protocols and reports, review and evaluate stability data, write and evaluate investigations, and address compliance challenges related to stability
- Collaborate with Quality partners to identify quality-critical tests and acceptance criteria to design appropriate stability studies
- Interface with Quality partners to ensure that the samples are analyzed, and the data is reported in a timely manner
- Interface with Operations and Supply Chain to ensure storage and packaging requirements of the stability protocol are achieved
- Analyze existing data and literature to generate stability reports, as appropriate
- Participate in the weekly Product Selection Committee meetings, and New Product Integration meetings, as applicable
- Collaborate with Commercial and Quality teams on New Product offerings to understand customer and market requirements, and provide shelf-life establishment recommendations based on the stability process and existing product knowledge
- Perform out-of-specification investigations on stability data per GGUI procedures
- Coordinate with 3rd party vendors to obtain necessary support for stability studies
- Assist in audit and compliance program to meet IPEC and applicable ISO laboratory accreditation requirements, including statistical analysis of data
- Perform additional duties as assigned.
|Skills & Qualifications|
- Bachelor of Science Degree in Chemistry, Biochemistry or related scientific fields
- Minimum 5 years of analytical or R&D laboratory experience in a GLP/GMP industry environment
- Must be able to collaborate effectively in a team setting
- Good writing, presentation, communication, and organizational skills
- Understanding of chemical stability principles, preferably ICH stability guidelines.
- Possesses Company values of honesty, integrity, respect, commitment and open to change while modelling the Company Core Principles in all activities
- Ability to foster collaborative, cross department relationships to meet common objectives.