QA Operations Specialist

Posted 28 Apr 2020

Cleveland, Ohio - United States

Req Id 205711

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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:

Support the Quality needs of the Cleveland site by performing routine QA activities.  Support the Cleveland site with responsibilities including: batch record review, helping maintain and improve Cleveland Quality Systems, such as auditing, training, change control, complaint handling, and NCR handling. Disposition finished product by evaluating all aspects of product versus analytical, production, packaging and labeling specifications in accordance with established procedures.

  • Review production, packaging, and QC records to ensure accuracy and completeness.
  • Disposition raw materials, intermediates, and finished product as appropriate. 
  • Actively participate in the implementation and improvement of Quality Systems.
  • Routinely support and recommend ongoing process improvements with the department and the organization, ensuring efficient and value-added processes.
  • Work with Production, QC, Purchasing, Packaging and Materials Management to resolve issues with product releases and failure investigations.
  • Ensure restriction of non-conforming products from sale as needed and ensure all necessary personnel (internal and external) are notified. 
  • Assist with complaint handling and investigations.
  • Follow-up with areas to ensure completion of corrective action tasks within the specified timeline.
  • Present various quality systems training topics to production, laboratory and quality personnel.

 

Who You Are:

 

Basic Qualification:

  • Bachelor’s Degree in Life Sciences, Pharmacy or Chemical Engineering and 4+ years of QA experience

OR

  • Bachelor’s Degree in any discipline and 6+ years of QA experience

OR

  • 10+ years of QA experience

 

Preferred Qualification:

  • QA role in a chemical or GMP regulated manufacturing environment
  • Prior experience in a GMP environment 

RSMS


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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