Sigma
Senior Associate Quality Scientist- 2nd Shift
Sigma, Saint Louis, Missouri, United States, 63101
Senior Quality Control Associate Scientist
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. Minimum Qualifications: Bachelor's degree in Chemistry, Biochemistry, Biology, or Engineering discipline 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, 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.
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. Minimum Qualifications: Bachelor's degree in Chemistry, Biochemistry, Biology, or Engineering discipline 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, 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.