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Stability Coordinator II

Integrated Resources, Inc

Lexington, Massachusetts

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Analytical Development, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Clinical Research, Code of Federal Regulations, Communication Skills, Cross-Functional, Data Management, Detail Oriented, Drug Products, Equipment Maintenance/Repair, Follow Through, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), ICH Regulations, Identify Issues, Information Technology & Information Systems, Inventory Management, Laboratory Information Management System (LIMS), Manufacturing, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Operations Processes, Organizational Skills, Presentation/Verbal Skills, Quality Assurance, Quality Control, Regulations, Rehabilitation Nursing, Reporting Dashboards, Statistics Software, Team Lead/Manager, Test Lab, Test Plan/Schedule, Testing, Time Management, Writing Skills
LOCATION
Lexington, Massachusetts
POSTED
2 days ago
Stability Coordinator IIIntegrated 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.Job DescriptionThe 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 activitiesQualificationsA BS in biotechnology, biology, chemistry or similar field3-5 years of industry experience with quality functions: quality control, manufacturing, or project managementGeneral knowledge of ICH guidelines for stabilityStrong organizational skills and attention to detail are requiredAbility to operate in a GLP and GMP environmentExcellent written and oral communication skills and must be able to interact with a cross-functional team membersProject management experience and/or experience with LIMS, JMP, Design Expert, or other statistical software are a plusStrong skills with Microsoft Office applications (Excel, Office, Powerpoint, Outlook, etc.)

About the Company

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Integrated Resources, Inc