Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
The Stability Coordinator will be responsible for managing development stability studies including study execution and data management in alignment with regulatory guidance documents (CFR, ICH, etc.).
In this role, the Stability Coordinator will interact with and support multiple cross-functional teams to meet stability needs for clinical programs in all stages of development.
The Stability Coordinator will initiate stability studies for drug substance and drug product, maintain stability equipment, perform stability pulls, coordinate sample preparation/submission and testing, publish a monthly stability pull/testing status dashboard, follow through for on-schedule data delivery, receive, summarize and archive stability data, and manage stability inventory.
The Stability Coordinator will interact with members of Drug Product and Combination Development, Analytical Development, Quality Control, Quality Assurance and outside test labs to create and manage the stability pull schedule based on the requirements of the protocols and industry guidance, and the needs of customers.
The individual will be able to identify when an issue needs to be elevated and can manage the elevation appropriately.
The Stability Coordinator will support generation and implementation of related quality systems (deviations, change controls, etc.) and assists in the development and maintenance of applicable standard operation procedures and related systems for congruent management and coordination of stability activities
A BS in biotechnology, biology, chemistry or similar field
3-5 years of industry experience with quality functions: quality control, manufacturing, or project management
General knowledge of ICH guidelines for stability
Strong organizational skills and attention to detail are required
Ability to operate in a GLP and GMP environment
Excellent written and oral communication skills and must be able to interact with a cross-functional team members
Project management experience and/or experience with LIMS, JMP, Design Expert, or other statistical software are a plus
Strong skills with Microsoft Office applications (Excel, Office, Powerpoint, Outlook, etc.)
| Location | Lexington |