Overview
Biopharma Production QA Analyst Jobs in St. Louis, Missouri, USA at Avantor
Location: St. Louis
The Opportunity:
Works independently under close supervision, collaborating with various departments to perform and validate test cases based on quality requirements. Responsible for ensuring that the end product meets minimum quality standards, is fully functional, and user-friendly. Interpret and implement quality assurance standards, providing accurate and comprehensive feedback to colleagues. Develop and execute test plans to meet objectives.
Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the product. Identify and remedy defects within the production process.
How you will thrive and create an impact:
Knowledge of current Good Manufacturing Practices (cGMPs) and regulations from USP, EP, JP, IPEC, and the FDA (CFR Part 210 and 211) related to managing stability programs.
Assist in preparing stability protocols and final reports.
Plan, organize, and manage stability studies following ICH and FDA guidelines.
Review and analyze stability data to identify trends and report findings.
Maintain stability chamber inventory and monitor chamber performance.
Handle incoming stability samples, including logging, labeling, and storage, ensuring safety and compatibility requirements are met.
Manage the distribution of stability samples to appropriate laboratories.
Coordinate stability studies, track schedules, and ensure timely execution of protocols.
Generate and distribute monthly stability dashboards with key data to cross-functional teams.
Oversee disposal or shipping of completed samples.
Represent the stability program as an SME during audits.
Schedule and manage transportation of incoming samples.
Collaborate with teams to maintain data integrity and ensure timely testing and reporting.
Assist with Out of Specification investigations for stability studies.
Who you are:
Bachelor’s degree in science, chemistry, or engineering.
5+ years of laboratory experience, including stability testing.
What we are looking for:
Knowledge of cGMPs and regulations from USP, EP, JP, IPEC, and FDA related to stability programs.
Disclaimer: The above statements describe the general nature of the work and are not exhaustive of all responsibilities, duties, and skills required. Avantor is an equal opportunity employer.
Why Avantor?
Dare to go further in your career.Join our global team of over 14,000 associates passionate about discovery and overcoming challenges to advance life-changing science.
The work we do changes lives—bringing new treatments to market, enabling medical devices, and more. Contribute your talents, learn, and grow with Avantor.
We support your career growth through our diverse, equitable, and inclusive culture, learning experiences, and commitment to making a difference.
Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and a VEVRAA Federal Contractor. We do not discriminate based on sex, gender identity, sexual orientation, race, color, religion, national origin, disability, veteran status, or other protected characteristics. For accommodations, contact r
Learn more about your rights here.
3rd Party Non-Solicitation Policy:
Submitting candidates without a formal assignment or contracting with Avantor may result in forfeiture of fees. We work with a preferred supplier list and do not accept solicitations outside our process.
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Title: Biopharma Production QA Analyst
Company: Avantor
Location: St. Louis, Missouri, USA
Category: Quality Assurance – QA/QC, Healthcare
