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Stability Coordinator
2 months ago
Pay Rate: $25-27/hour
Summary:Support stability chamber and GMP stability sample management in accordance with Customer, Company, and applicable regulatory requirements.Responsibilities:
- Receive, store and ship GMP stability sample material while maintaining the cleanliness of the stability chambers and staging areas as per relevant safety and quality procedures.
- Label, store and record the inventory of GMP stability samples. Enter sample related conditions, quantities, testing requirements, specifications, and pull dates in an electronic database (i.e. LIMS). Pull samples in accordance with the specified study protocol and submit to designated lab(s) per testing requirements.
- Generate stability study protocols working closely with relevant laboratory managers and Quality Assurance staff to ensure Customer, Company and regulatory requirements are met.
- Coordinate with Project Management, Laboratory, Manufacturing and Quality Assurance personnel to ensure the proper documentation is received and approved in order to process orders, receive and/or release materials.
- Maintain required level of chain of custody/documentation when transferring stability samples and testing documentation to recipients to ensure traceability and compliance with specifications and procedures.
- Conduct inventory reconciliation as required ensuring accurate counts of all inventory items.
- Ensure all items received are accurately accounted for and that no materials with any observed signs of damage are accepted.
- Maintain workspace cleanliness by adhering to the 5S method of organization.
- Abide by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.
- This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.
- Minimum 2-4+ years of industry related work experience.
- Bachelor's degree or equivalent in scientific discipline required.
- Knowledge of cGMP, FDA regulations, and ICH guidelines as they pertain to contract laboratory operations.
- Knowledge of USP, Pharm. Eur. and other compendial methods and procedures.
- Rudimentary knowledge in the use of LIMS and electronic documentation systems (i.e. MasterControl).
- Knowledge of job-related techniques and principles with an ability to work on routine assignments independently, requiring instructions and close supervision on new assignments.
