Specialist, Quality Assurance

Posted 11 Nov 2019

Madison, Wisconsin - United States

Req Id 199371


A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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:


You will act as a QA Expert to support custom products within our contract development and manufacturing business, which includes customer-facing activities.  You will work in a global quality team that shares systems and processes.  You will have close cross departmental interactions with internal teams in the contract development and manufacturing site. 


Your key responsibilities include work directly with customers for quality related questions or issues on clinical and commercial programs. You will work closely with operations, project management, and regulatory to ensure programs are established and maintain in a compliant state.  This role will also support the change control program for all product quality-related changes to documents, specifications and methods. You will auditi executed GMP documentation and other applicable procedures to ensure compliance and completeness per ICH Q7. You will be responsible for release of APIs for human use. You will ensure compliance with client specific quality agreements. You will be instrumental in creating and maintaining policies and operating procedures to strengthen quality compliance.  This position will use common quality organization tools such as: SAP, electronic documentation systems, Trackwise and LMS.


Who you are:  


Basic Qualifications:

  • Bachelor or Master level of education in chemistry or life sciences with a strong emphasis in chemistry

Preferred Qualifications:

  • Minimum of 7 years of relevant industry experience and/or QA related to active ingredients, excipients, or other pharmaceutical substances
  • Expert regarding ICH Q7 cGMP, 21 CFR Part 211, 21 CFR Part 11
  • Detail oriented
  • Demonstrate good communication & project management skills


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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