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Stability Coordinator

Location

Whippany, NJ, USA

Department

Quality Control

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The Stability Coordinator is responsible for review, set-up, and coordination of stability studies withing the Quality Control Laboratory. The Position supports both commerial and development stability.

  • Receive stability batches for QC as well as Development, set up stability studies in the Novatek stability software system. Label samples appropriately and place them in boxes, which will be stored in designated stability chambers for stability study. Check all the paperwork for completelness along with the samples.
  • Pull stability samples from stability chambers per testing schedules for analysis. Create relevant paperwork for each stability sample with all the information and provide them to chemists and/or microbiologist along with samples. If outside testing is required, samples along with proper paperwork will be coordinated with QC sample coordinator.
  • Prepare Annual Product Review reports for stability data.
  • Upon completion or discontinuation of a stability study, remove the samples from the chamber and dispose of them.
  • Monitor temperature and humidity for stability chambers daily and change each chart paper once a week. Report any deviations to the supervisor immediately.
  • Enter the results into the Novatek stability software system to generate the stability summary report for each individual stability batch, if needed.
  • Provide training and mentoring to other stability coordinator(s) as needed.
  • Prepare, write, and coordinate stability protocol for specific products and regulatory guidance within the Stability group.
  • Acts as backup for Stability Supervisor as necessary.
  • Demonstrate the ability to manage several projects simultaneously.
  • Participate in internal and external audits.
  • Perform other related assignments and duties as assigned and required.
  • Other duties as assigned.
  • Demonstrate computer literacy with proviciency in Microsoft Office software.
  • Strong organizational skills desired.
  • Strong oral and written communication skills, including effective listening.
  • Understanding of stability study structure and documentation.
  • Understanding of ICH and regulatory guidelines.
  • Must be able to lift up to 25 pounds
  • Must be able to move in confined spaces
  • Must be able to remain sedentary for periods of time
  • Must be able to move about the facility
  • Associate college degree in Biology, Biochemistry, Chemistry, or closely related scientific field
  • Minimum of 2 years’ experience working directly in stability programs for pharmaceutical industry