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Sr. Associate Quality Scientist

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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:

At MilliporeSigma, the Sr. Associate Quality Scientist is responsible for the cGMP analytical data review and documentation generated during laboratory analysis.

 

  • Review data consisting of 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.
  • Review techniques specific, but not limited to HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
  • Responsible for the review of protocols and standard operating procedures as well as technical reports. 
  • Review deviations, OOS/OOTs, change controls, and CAPAs.
  • Participate in process improvement initiatives.
  • Work in a team environment.
  • Maintain a clean and safe work area.
  • Support the department in maintaining the laboratory in an audit-ready state.
  • Perform analytical data review of cGMP data in support of the quality control group to ensure accuracy and quality of data.
  • Exercise judgment within generally defined procedures and practices.
  • 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 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:

 

 Basic Qualifications:

  • Bachelors Degree in Chemistry, Biology, Chemical Engineering, or related discipline life science discipline with 1+year of experience in a cGMP, or pharmaceutical manufacturing environment OR  Associates Degree in Life Sciences with 3+ years of experience in a cGMP or pharmaceutical manufacturing environment OR High School Diploma, or GED Equivalent with 5+ years of experience in a cGMP or pharmaceutical manufacturing environment

 

 Preferred Qualifications:

  • Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211) and/or Q7A Good Manufacturing Practice Guidance for API’s
  • Excellent organizational, written and verbal communication and interpersonal skills.
  • Knowledge and understanding of organic analytical chemistry

 

RSRMS

 

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:  217106
Location:  Madison
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Chemistry, Scientist, Pharmaceutical, QC, Science, Quality

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