Sr. Associate Quality Scientist 3rd shift
MilliporeSigma

Madison, Wisconsin

Posted in Science and Research


This job has expired.

Job Info


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:

At MilliporeSigma, the Senior Associate Quality Scientist position is responsible for the cGMP analytical data review and paperwork generated during laboratory analysis in the quality control division.

Third Shift Position - Monday - Thursday 9:00pm - 7:30am

  • Review the following: 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.
  • Utilize techniques for review such as HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
  • Responsible for data review of protocols and standard operating procedures as well as technical reports.
  • Review deviations, OOS/OOT's, change controls, and CAPA's.
  • Participate in process improvement initiatives, working in a team environment while maintaining a clean and safe work area.
  • Support the department in maintaining the laboratory in an audit-ready state are other duties.
  • Perform analytical data review of cGMP data in support of the quality control group to ensure accuracy and quality of data.
  • Work on complex problems in which analysis of data requires an in-depth evaluation of various factors.
  • Exercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining results.
  • Solve problems and make decisions with minimal assistance.
  • Interpret analytical data (including FT-IR, 1H NMR, MS).
  • Apply problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor.
  • Meet with internal project groups to keep projects on track.
  • Maintain projects and timelines with minimal oversight.
  • 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.
  • Work cooperatively within the QC department and with other departments to achieve project goals.
  • Communicate with project management and provide technical updates
  • Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable
  • Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.

Who You Are

Basic Qualifications:
  • Bachelors Degree in Chemistry, Biochemistry, Chemical Engineering or related life science discipline
  • 3+ years of experience in a GLP or cGMP analytical laboratory environment

Preferred Qualifications:
  • Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detail
  • Ability to work in an analytical testing lab with hazardous and toxic chemicals
  • Knowledge and understanding of organic analytical chemistry
  • Adequate technical writing skills to generate project reports

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!

Curious? Apply and find more information at https://jobs.vibrantm.com

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.

Job Requisition ID: 220576

Location: Madison

Career Level: D - Professional (4-9 years)

Working time model: full-time


This job has expired.

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