Position title
Associate degree jobs
Employment Type
Part-time
Base Salary
USD20-USD35 Per hour
Job Location
United States
Remote work from: USA
Description
  • 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
Date posted
10 February 2024
Valid through
21 May 2025
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