Quality Control Senior Analyst 1

Posted 14 Aug 2021

Verona, Wisconsin - United States

Req Id 227592


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.


This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.


Your Role:

The Scientist, Quality Associate, Sr position is responsible for the cGMP analytical laboratory analysis in the raw material - quality control division of MilliporeSigma. Analysis may consist of all/some of the following; incoming raw material analysis, routine final product analysis, in-process tests, method validation/qualification, cleaning, environmental monitoring to support quality control activities at the Madison and Verona sites. Analysis includes techniques specific to but not limited to HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. Other responsibilities may include initiation and review of deviations, OOS/OOT’s, change controls, and CAPA’s. Additionally, 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. The Scientist, Quality Associate, Sr position will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties. 

 Perform analytical data analysis of cGMP data in support of the quality control group to ensure accuracy and quality of data.

  • Work on problems of diverse 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.
  • 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 as applicable.
  • Support all data integrity initiatives and strive for right first time
  • Work near moving mechanical parts. 


Physical Attributes: 

  • Regularly sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for at least 50% of the time.
  • Wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant sleeves, gloves, safety shoes, and half/full face respirators) and other personal protective equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles. 
  • Lift and/or move up to 25 pounds unassisted to complete assignments
  • Lift more poundage with assistance
  • Speak, hear, taste, and smell. 
  • Utilize specific vision requirements include close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus.   


Who You Are:
Minimum Requirements:

  • B.S. in Chemistry, BioChemistry or related biological sciences
  • 1+ year(s) in a cGMP analytical laboratory environment, or equivalent industry experience



Preferred Qualifications:

  • Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7
  • 3+ years in a cGMP analytical laboratory environment, or equivalent industry experience
  • Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detail 
  • Knowledge and understanding of analytical chemistry techniques preferred
  • Ability to work in analytical testing lab with hazardous and toxic chemicals.



Who you are:


  • B.S. in Chemistry or related biological sciences.
  • 2-5 years in a GLP or cGMP analytical laboratory environment, or equivalent industry experience.
  • Excellent written and verbal communication skills, as well as excellent documentation practices. 
  • Ability to work in analytical testing labs with hazardous and toxic chemicals. 
  • Knowledge and understanding of organic analytical chemistry are preferred.

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.

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