Job details
Job type full-time
Full job description
Position overviewthe 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 facilitiesThis role is responsible for the development, review, and approval of stability protocols and stability reports, and management of the associated dataThis role will effectively collaborate with appropriate departments and 3rd party vendors to ensure stability protocols are executedThis role will review analytical data generated during stability studiesThis role is remote with required travel to connecticut, kentucky, and ireland sites as appropriate.
Duties & responsibilitiesthe stability coordinator will:
Ensure compliance of the stability program to internal procedures and appropriate regulatory requirementsDesign 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.
Qualities
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.
Job type: full-time
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Posted 5 days ago
