Associate degree jobs
General Maintenance of GMP and non-GMP stability chambers Inventory of stability samples in each stability chamber, i.e. freezers, cryostorage systems, cold rooms/refrigerators and incubators. Inventory of raw material retain samples Defrosting and cleaning of stability chambers (as needed) Water refill for applicable incubators; check and re-supply of carbon dioxide tanks for applicable incubators Check and re-supply of liquid nitrogen (LN2) Dewars for cryostorage systems Monitoring, tracking and coordination with BioAnalytics Operations group of routine calibration, validation and PM (as applicable) of freezers, cryostorage systems, cold rooms/refrigerators, incubators and ovens with Metrology group, Validation group and other groups as applicable Sample Handling Review of schedule and preparation in advance of pulls, receipt and shipping Receiving of raw materials, drug substances and/or drug products and other materials from internal and external manufacturer Sample labeling, according to procedure, any materials that are received without proper labeling Distribution of samples to on-site testing groups and storage of samples at the appropriate conditions according to applicable documentation LIMS GMP documentation of sampling, pulls and distribution Preparation, documentation and shipping of raw materials, drug substances/products and other materials according to established procedures Retrieval of TempTale data/documentation of received materials onsite and from receiving external testing laboratories Packout of samples for offsite storage and for shipping to external testing laboratories Disposal of samples at their retention end date according to procedures Adherence to Stability Study Protocols Ensure most recent versions of sampling plans and stability protocols are followed Follow specific instructions in sampling plans and stability protocols Follow GMP documentation practices Mobile Device Carrier to Address Alarms (during regular business hours) Carry mobile device used to monitor alarms generated by freezers, cryostorage systems, cold rooms/refrigerators and incubators Notify point of contact for any observed alarms Obtain alternate unit to house materials Send notification to BioAnalytics staff on alarms triggered by impacted units
Qualifications
Associates degree with 0-2 years of experience Ability to drive a vehicle with appropriate licensure, may lift to 50 lbs Good organization and communication skills (oral/written) Standing for long periods on some days; potential exposure to investigational drug substances/products Apply Job!