Stability Specialist

Merck • Saint Louis, MO

3d

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. 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.

Requirements

• Bachelor's Degree in Life Science (Biology, Chemistry, Biochemistry, etc.)

Nice To Haves

• 2+ years lab 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level