Associate Quality Scientist-QC Investigator

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:

The Associate Quality Scientist at MilliporeSigma in St. Louis, MO (Cherokee) supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice guidelines (ICHQ7) and Drug Products. In this role, you will be overseeing out of specification (OOS) and out of trend (OOT) investigations and deviation investigations associated with release, stability, and in-process samples. The position is also accountable for execution and management of quality control CAPA projects, Effectiveness check and change controls. The position reports to Senior QC Supervisor.

• Shift: Monday-Friday 8am-5pm.
• Manage OOS, OOT, Deviations, and CAPAs.
• Perform investigations (OOS, OOT, and Deviations).
• Perform root cause analysis using industry standards such as 5 Why’s, Fishbone diagram etc.
• Determine relevant corrective and preventative action.
• Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.
• Interact with the laboratory analyst, data reviewer, manufacturing, quality assurance, packaging, and development personnel to ensure adequate Root Cause is identified.
• Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA).
• Draft Operating Procedures, Specifications, and other QC controlled documents.
• Occasionally support and perform detailed data review for analytical data packets generated by quality control for compliance with cGMP, internal OPs and specifications.
• Draft OOS and OOT trend reports.
• Provide trend reports of quality events/invalids.
• Maintain compliance with company policies, regulatory requirements, quality specifications, and safety standards.
• Perform quality review of documentation and processes Provide trend reports of quality events.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Additional duties assigned by the QC management.

Who You Are

Minimum Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or other life science discipline.

OR

• Associate degree in chemistry, Biochemistry, Biology, or other life science discipline.
• 3+ years of experience working in a cGMP laboratory environment.

 Preferred Qualification:

• General understanding of multiple techniques includes UV, HPLC/UPLC, icIEF, Solo-VPE, CGE, SEC, ELISA, and LC-MS.
• General understanding on Monoclonal antibodies (mAb) and antibody-drug conjugates.
• Understanding on Chromeleon.
• Root cause analysts and corrective and preventive actions.
• Data integrity, GDP and ALCOA.
•  Experience in multi-disciplinary project management, along with strong communication and decision-making skills.
• Experience writing technical documentation and reports.
• Strong computer skills, including proficiency in Word, Excel, and PowerPoint.
• ICH Guidelines.
• Highly organized and capable of working in a team environment with a positive attitude under minimal supervision.

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html