A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Senior Associate Quality Scientist at MilliporeSigma in Verona, WI is responsible for the routine laboratory analysis of cGMP samples with a primary emphasis in stability study analysis.
Perform analysis of stability study samples.
Exercise judgment within defined procedures and practices to obtain solutions.
Write stability protocols, maintain stability chambers/programs, review/manage stability reports, interact with customers to support stability program as needed.
Assist with development of testing methods to support cleaning verification program, validate or verify methods, and perform cleaning verification as needed.
Perform instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair as needed.
Perform preliminary review of analytical data for accuracy and quality.
Perform method validations/qualifications/transfers and write technical reports as needed.
Demonstrate proper laboratory techniques during analytical testing for raw materials, in-process, final products, intermediates, and stability samples. Recognize problems with analytical test results or method performance and take appropriate steps to address them. Testing will involve the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
Participate in OOS and OOT investigations via testing and good documentation.
Apply good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective and/or preventive actions with assistance from supervisor.
Perform requalification of reference standards and maintain reference standard inventory/documentation.
Write and revise SOPs including raw material, intermediate, and final product specifications.
Document testing properly and in a timely fashion, including keeping laboratory notebooks accurate and up to date.
Meet with internal project groups to keep projects on track.
Maintain projects and timelines independently.
Help train new or less experienced personnel on procedures, analytical techniques, and methodologies.
Work cooperatively within the QC department and other departments to achieve project goals.
Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable.
Who you are:
Bachelor's Degree in Chemistry, Biology, Chemical Engineering, or related life science.
2+ year of experience in a cGMPor pharmaceutical manufacturing environment.
Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211) and/or Q7A Good Manufacturing Practice Guidance for APIs.
Excellent organizational and interpersonal skills with outstanding written and verbal communication abilities.
Knowledge and understanding of organic analytical chemistry.
Ability to solve problems and make decisions with assistance.
RSRMS MilliporeSigma Millipore Sigma
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