Senior Associate Quality Scientist (QC Data Review and investigation)

Merck KGaA•Saint Louis, MO

30d•$23 - $42•Onsite

About The Position

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.

Requirements

Bachelor's Degree in Science (Chemistry, Biochemistry, Biology) or Engineering (Chemical, Process, etc.)
3+ year of work experience in a lab settings/data review

Nice To Haves

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

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.