The businesses of Merck KGaA, Darmstadt, Germany
Senior Associate Quality Scientist- 2nd Shift
The businesses of Merck KGaA, Darmstadt, Germany, Saint Louis, Missouri, United States, 63146
Work Location: St. Louis, Missouri
Shift: Yes
Department: LS-SC-POKQC5 Cherokee QC Group 5
Recruiter:Guadalupe Barragan
Hiring Manager: Heather Robinson
This information is for internals only. Please do not share outside of the organization.
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 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 Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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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 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 Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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