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 Senior Quality Control Associate Scientist at Millipore Sigma 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 release, stability and in-process testing (Drug Substances and Drug Products of ADC and Bio Organics). 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.
Shift: Monday-Friday 2 pm to 10.30pm.Review analytical data and documentation to ensure compliance with cGMPs, GDP, FDA, EMA, ICH Guidelines, and ALCOA+ principles.Evaluate chromatographic integrations, calculation spreadsheets, audit trails, and time-of-use logs on cGMP instrumentation.Ensure laboratory testing complies with procedures, protocols, test methods, and applicable SOPs; work with lab personnel to correct errors and reinforce a strong cGMP culture.Demonstrate technical expertise with analytical equipment and techniques such as HPLC, SEC, ELISA, iCIEF, UV-Vis, pH meters, SOLO VPE, and others.Use computerized systems (e.g., Chromeleon, Labx) to analyze data and generate reports accurately.Prioritize tasks, meet deadlines, and coordinate with team members to improve data review processes and ensure GDP compliance.Collaborate effectively with QC Analysts, Group Leaders, and cross-functional departments within 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, or Engineering discipline3+ 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, SAP and LIMs systems.Knowledge of current federal, local, and international regulations regarding the Testing, production and release of raw materials, drug substances and 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 believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!