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Quality Specialist I - Validation Audits

Posted 07 Nov 2017

Rockville, Maryland - United States

Req Id 168233

Details

Who We Are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany – a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.


 

QA Technical Services is responsible for QA review of new assay and equipment validation to include pre- and post- execution documentation.

 

Your role: Supports Operations department(s) in implementing new assays and changes to existing assays. Reviews validation protocols, reports, and other validation deliverables for various types of equipment, assays, and spreadsheets. Reviews SOPs/other documents for compliance requirements. Reviews change control documentation for compliance requirements

Who you are: 

  • Proficient working knowledge of standard validation practices. 
  • Introductory to proficient working knowledge of Part 11 compliance. 
  • BS in Life Science with 0-2 years experience in Quality Assurance.
  • Experience writing and reviewing governing documents particularly in a validation and/or calibration environment.

What we offer: Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.

MilliporeSigma 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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