Senior Associate Quality Scientist (QC Data Review and investigation) at Millipore S.A.S.

St. Louis, Missouri, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Feb, 26

Salary

42.0

Posted On

23 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Data Review, GMP Compliance, Analytical Instrumentation, Documentation, Root Cause Analysis, Collaboration, Process Improvement, Problem Solving, Communication, Training, Chromatography, Electrophoretic Testing, Quality Management Systems, LIMs Systems, Attention to Detail

Industry

Biotechnology Research

Description

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. Shift: Monday-Friday 2pm-10:30pm. Review analytical data to ensure compliance with cGMPs, GDP, FDA, EMA, and ICH guidelines, maintaining ALCOA+ principles and adherence to laboratory procedures, test methods, and protocols. Evaluate and verify data integrity, including reviewing time-of-use logs, audit trails (e.g., Chromeleon, LabX), and ensuring accurate electronic data analysis and report generation. Demonstrate strong technical knowledge of analytical instrumentation and methods (e.g., HPLC, SEC, ELISA, LC, pH, iCIEF, SOLO VPE, UV-Vis) and support analysts in correcting documentation errors while promoting a cGMP-focused culture. Perform and manage quality investigations including OOS, OOT, deviations, and CAPAs; conduct root cause analyses (e.g., 5 Whys, Fishbone) and determine appropriate corrective and preventive actions. Collaborate with QC analysts, group leaders, QA, manufacturing, packaging, and development teams to gather information, interview personnel, and ensure accurate and complete laboratory investigation reports (e.g., in TrackWise). Support continuous process improvement by providing feedback, coordinating with team members, improving GDP practices, and contributing to tracking, timeliness, and completion of open tasks. Serve as a key QC team member, with data review as the primary responsibility, showing strong prioritization, organizational skills, attention to detail, and multitasking ability. Who you are: Minimum Qualifications: Bachelor’s Degree in Science (Chemistry, Biochemistry, Biology) or Engineering (Chemical, Process, etc.) 3+ year of work experience in a lab settings/data review Preferred Qualifications: Exposure to wet chemistry, chromatography or electrophoretic testing is preferred. 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 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 Pay Range for this position $23.00-$42.00 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. 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!

Responsibilities

The Senior Associate Quality Scientist will review documentation and data for GMP products, ensuring compliance with regulatory guidelines. They will also manage quality investigations and collaborate with various teams to ensure accurate laboratory reports.