Quality Specialist 2

Posted 11 Jun 2020

Rockville, Maryland - United States

Req Id 207198

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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:

 

Contributes to or impacts the results of the Quality Assurance (QA) team and is accountable for the quality of own work. Receives clear instruction, guidance and direction from more senior level roles or solves problems of low complexity independently by identifying and selecting solutions and by analyzing information. 

 

The individual performs a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation. 

  • Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records
  • Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis
  • Review and approve validation files for systems and assays
  • Review and approve minor, major and critical impact deviations / OOS records
  • Conduct trend analysis for deviations and review / approve applicable CAPA records
  • Conduct laboratory inspections to include commissioning and/or internal audits
  • Provide support for client regulatory submissions, client audits and supplier audits 
  • Review and approve client and supplier quality agreements 
  • Responsibility for ensuring that turnaround times are met
  • Work with cross-functional teams and builds networks within QA and Operations departments 
  • Collaborate with various teams to identify and implement improvements

 

Who you are:

Minimum Qualifications:

 

  • Bachelor’s degree in scientific field (i.e. Biology, Biochemistry, etc.) or technical field (i.e. Engineering, etc.) 
  • 1+ years' experience in Quality Assurance or related field within a GxP environment

 

Preferred Qualifications:

 

  • 2+ years’ experience in Quality Assurance or related field within a GxP environment
  • Acts ethically and ensures quality of own work and that of others
  • Open-minded, flexibility and works with agility
  • Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity)
  • Strong communication and interpersonal skills

 

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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