Validation Specialist, Sr. Quality

Posted 23 Oct 2019

Carlsbad, California - United States

Req Id 199376

Details

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:

Collaborate with line functions and validation departments to complete validation activities pertaining to planning, installation, qualification, release for use, and retirement

Serve as System Administrator for all Validated Computer Systems on Site Work cooperatively with system owners to ensure CSV compliance, timely and appropriate audit trail reviews, and access and user control.

In this role you will lead site Data Integrity program, QA review and approval of Equipment and System Validations that have a CSV element. Review and approve SOPs, work instructions and templates. Additionally, you will be reviewing and approving validation protocols and final reports, and ensuring that validation documentation is adequate, correct, and controlled appropriately, perform risk assessments for computerized systems/applications and provide input regarding compliance requirements for GxP systems. You will need to effectively communicating validation requirements to affected departments within the organization and ensuring that validation is performed in a cGMP compliant manner, have outstanding client and interdepartmental communication skills, have thorough understanding of both US and EU validation requirements for facilities, utilities, equipment, and biological processes and support regulatory inspections, client, vendor and internal audits.

 

Who You Are:

 

Basic Qualifications:

  • Bachelor’s degree in Science OR IT disciple  
  • 5+ years’ experience in quality and/or validation experience in a GMP environment
  • 3+ years’ experience with IT, Computerized System Validation AND Data Integrity

 

Preferred Qualifications:

  • Experience with MS Word and Excel preferred
  • Experience in Quality Control or with Analytical Systems preferred
  • Experience in a Systems Administration role with computerized systems experience preferred

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.

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