Stability Analyst

Cell Marque Corporation•St. Louis, MO

7d•$24 - $43•Onsite

About The Position

MilliporeSigma is seeking a highly motivated and detail-oriented Stability Studies Specialist to join our team. The Stability Specialist will be responsible for developing, executing and analyzing stability studies for IVD products. This role will ensure compliance to regulatory guidelines, such as IVDR.

Requirements

Associate Degree in Life Science (Biology, Chemistry, Biochemistry, etc.)
OR
High School Diploma or GED
2+ years of laboratory experience

Nice To Haves

2+ years 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

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.