Senior Associate Quality Scientist 1 at Merck Aktiebolag

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.
Your Role:
The Senior Associate Quality Scientist (Data Reviewer) role at MilliporeSigma in Verona, WI is responsible for the cGMP analytical data review and paperwork generated during laboratory analysis in the quality control division of MilliporeSigma. Data review may consist of routine final product analysis, in-process tests, raw material analysis, method validation/qualification, cleaning, environmental monitoring, and/or other data generated to support quality control activities at the Madison and Verona sites. Review of data includes techniques such as HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD, among other tests and instruments. This position also is responsible for data review of protocols and standard operating procedures, as well as technical reports. Other responsibilities include review of deviations, OOS/OOTs, change controls, and CAPAs. Additional responsibilities include participation in process improvement initiatives, working in a team environment, maintaining a clean and safe work area, and supporting the department in maintaining the laboratory in an audit ready state are other duties. Our organization also encourages a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.
  • Perform analytical data review of cGMP data in support of the quality control group to ensure accuracy and quality of data
  • Work on problems diverse in scope, in which analysis of data requires evaluation of identifiable factors
  • Exercise judgment within generally defined procedures and practices
  • Solve problems and make decisions with assistance
  • Meet with internal project groups to keep projects on track
  • Maintain data review turnaround times and additional timelines with minimal oversight
  • Support review of OOS and OOT investigations, deviations, change controls and CAPA’s
  • Apply problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor
  • Write and revise SOPs including raw material, intermediate, and final product specifications
  • Work cooperatively within the QC department and with 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 where applicable
  • Support all data integrity initiatives and strive for first time go’s
  • Work in a safe manner and maintain the cleanliness of the work environment

Physical Attributes:
  • May wear appropriate protective gear, such as respirators and chemical protective clothing, for long periods of time while performing daily tasks
  • May involve occasional lifting and pushing of up to 50 pounds

Who You Are:
Minimum Qualifications:
  • Bachelor’s Degree in Chemistry, Biochemistry, or related Life Science
  • 2+ years of Quality Control experience in a laboratory or manufacturing setting

Preferred Qualifications:
  • 2+ years of experience performing data review in a cGMP analytical laboratory environment
  • Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detail
  • Desire to work in analytical testing lab with hazardous and toxic chemicals
  • Knowledge and understanding of analytical chemistry techniques

RSRMS Millipore Sigma MilliporeSigma
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
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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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