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

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