Stability Specialist

MerckSaint Louis, MO

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role MilliporeSigma is seeking a highly motivated and detail-oriented Stability Specialist to join our team. The Stability Specialist will be responsible for developing, executing and analyzing stability studies for IVD (In Vitro Diagnostic products). This role will ensure compliance to regulatory guidelines, such as ISO13485 and IVDR.

Requirements

  • Bachelor's Degree in Biology, Chemistry, Biochemistry or other Life Science discipline
  • 2+ years of laboratory or Quality experience
  • Good communication, interpersonal, and collaboration skills
  • Ability to work effectively in a cross-functional team environment
  • Detail-oriented, organized, and able to manage multiple projects simultaneously
  • Problem-solving and analytical skills

Nice To Haves

  • Previous experience with IHC testing
  • Previous experience writing stability protocols and reports

Responsibilities

  • Develop and implement stability protocols according to guidelines and internal SOPs
  • Execute testing for stability samples, ensuring accuracy and precision
  • Monitor and maintain stability chambers and associated equipment
  • Document all data accurately in electronic systems
  • Analyze stability data and generate reports
  • Interpret stability data to assess product shelf life and storage conditions
  • Identify and investigate stability trends and deviations
  • Prepare stability reports for regulatory submissions and internal documentation
  • Ensure stability studies are conducted in compliance with regulatory guidelines, such as IVDR, ISO 13485

Benefits

  • health insurance
  • paid time off (PTO)
  • retirement contributions
  • other perquisites
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