Quality Assurance Specialist, Investigations

Posted 22 Aug 2018

Carlsbad, California - United States

Req Id 180667


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 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: 

Determines the root cause and corrective action of investigations identified through various processes (i.e. root cause analysis, batch record review). Ensures that investigations identify true root cause and appropriate corrective actions in order to prevent recurrence.

Who You Are

  • Bachelor’s degree in life sciences or related scientific discipline
  • Previous experience working in pharmaceutical/GMP environment
  • Proven ability to conduct investigations, writing deviations and CAPA’s 
  • Proven ability to apply quality tools (Fishbone Diagrams, 5 Whys, etc.)
  • Must have experience with Trackwise
  • Essential and Critical Skills:
    • Good analysis, troubleshooting, investigation and communication skills, especially both written and verbal
    • Thorough understanding of the biopharmaceutical manufacturing process, current Good Manufacturing Practices and CAPA
    • Ability to put complex thoughts and issues into writing in such a manner than an educated, but uniformed reader can understand and make decisions based on the written investigation report
    • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    • The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl. 
    • The employee may be required to enter the clean room environment. 
    • The employee must have the ability to perform very complex tasks with attention to detail.

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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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