• 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

• 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

Services required primarily during regular working hours but could require working off-hours and weekends. Position requires working onsite between Framingham and Waltham and reliable, personal transportation to do so.

Position is full-time, Monday - Friday. 8:00-5:00pm are the hours. Candidates currently living within a commutable distance of Waltham, MA are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options.

• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.