Sr. Associate Quality Scientist-QC Data Review

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 Quality Control Senior Associate 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. This position reports to QC supervisor.

You will be responsible for reviewing the documentation and data generated for analysis of GMP products. This review may include data supporting raw materials, in-process, and/or final products (Drug Substances and Drug Products). You will be responsible for verifying that documentation and raw data meet good documentation requirements, are technically acceptable, all calculations are appropriate, and specifications are met.

• Review the data to comply with cGMPs, GDP, FDA, EMA and ICH Guidelines.
• Review analytical data to ensure ALCOA+.
• Ensure compliance of testing with laboratory procedures, test methods and protocols. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus and multitask on review of analytical laboratory data.
• Strong technical knowledge of various analytical equipment, techniques, and methodology (e.g. liquid chromatography, pH, iCIEF, SEC, ELISA, HPLC, SOLO VPE, UV Vis etc).
• Strong prioritization, organizational skills and detail oriented. Coordinate and discuss with other team members for continuous improvement of the data review process. Discuss and provide suggestions to QC analysts for continuous improvement of the GDP within cGMP requirements and applicable written SOPs, test procedures and methods Completion of work within the assigned time frame, including organization, monitoring and tracking of tasks.
• Review time of use logs on cGMP instrumentation and other analytical equipment. Review audit trails on computer systems used to acquire and process data from instrumentation (e.g., Chromeleon, Labx). Ability to use a computer to accurately analyze data and generate reports as needed.
• Interaction with QC Analysts and Group Leaders as well as managers of other departments as needed.
• Able to work as a team member with the QC Lab environment.

Additional expectations may include the review of new or updated procedures for both technical soundness and allowance for appropriate documentation.

Who you are:

Minimum Qualifications:
 

• Bachelor’s Degree in Chemistry, Biochemistry, Biology, Chemical Engineering or other life science.

• 3+ year of work experience in a lab settings/data review.

Preferred Qualifications:

• Exposure to wet chemistry, chromatography or electrophoretic testing.
• Communicate with others clearly and concisely, ability to work in a fast-paced environment.
• Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and Proofreading skills.
• Knowledge of Quality Management Systems and LIMs systems.
• Knowledge of current local, federal and international regulations regarding the Testing and release of raw materials, drug substances and drug products. Excellent oral and written communication.
• Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills.
• Ability to effectively train others on programs and procedures.
• Experience working with cross-functional teams/sites.

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