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MilliporeSigma · 5 days ago

Senior Associate Quality Scientist (QC Data Review and investigation)

St Louis, MO

Full-time

Onsite

Mid, Senior Level

$23/hr - $42/hr

3+ years exp

MilliporeSigma is a global leader in science and technology, committed to enriching lives through innovative solutions in Healthcare, Life Science, and Electronics. The Senior Associate Quality Scientist will support quality functions for Active Pharmaceutical Ingredients, ensuring compliance with manufacturing guidelines and performing data reviews and investigations.

BiotechnologyMedicalMedical Device

No H1B

Responsibilities

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

Qualification

Analytical instrumentationData integrity evaluationQuality investigationsManufacturing PracticeQuality Management SystemsChromatographyProblem-solving skillsCommunication skillsTeam collaborationOrganizational skills

Required

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

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