Stability Analyst (IVDR) at Cell Marque Corporation

St. Louis, Missouri, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Jun, 26

Salary

43.0

Posted On

22 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Stability Studies, IVDR Compliance, Protocol Development, Testing Execution, Chamber Monitoring, Data Documentation, Data Analysis, Report Generation, Shelf Life Assessment, Deviation Investigation, Regulatory Submissions, ISO 13485 Compliance, Communication, Collaboration, Problem-Solving, Analytical Skills

Industry

Biotechnology Research

Description

Work Location: St. Louis, Missouri Shift: No Department: LS-SC-PMLQD Cell Marque Quality Recruiter: Guadalupe Barragan Hiring Manager: Cheryl Prichard This information is for internals only. Please do not share outside of the organization. Your Role: 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. Who You Are: Minimum Qualifications: Associate Degree in Life Science (Biology, Chemistry, Biochemistry, etc.) OR High School Diploma or GED 2+ years of laboratory experience Preferred Qualifications: 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 Pay Range for this position: $24.00-$43.00 per hour. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Responsibilities

The Stability Specialist will be responsible for developing, executing, and analyzing stability studies specifically for In Vitro Diagnostic (IVD) products to ensure compliance with regulatory guidelines like IVDR. This involves executing testing, monitoring chambers, analyzing data, generating reports, and investigating trends or deviations.