Quality Specialist 1

9/2/2021

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

 

This role does not offer sponsorship for work authorization.  External applicants must be eligible to work in the US.     

 

Your Role:
As the Quality Specialist I at MilliporeSigma, you will perform 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 deviation records
  • Conduct laboratory inspections
  • The shift will be Sunday to Thursday, 8AM to 5PM

 

Who You Are:
Minimum Qualifications:

  • Bachelor of Science in Biology, Biotechnology, Chemistry or Bachelor of Arts degree in any science or technical related discipline


Preferred Qualifications:

  • 6+ months experience in Quality Assurance or related field within a GxP environment
  • Strong work ethic; ensures quality of own work and that of others
  • Takes responsibility for ensuring that turnaround times are met
  • Works with cross-functional teams and builds networks within QA and Operations departments
  • Open-minded, flexible and works with agility
  • Basic knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211 etc.)
  • Familiarity with International regulations (EMA, MHRA)
  • Strong verbal and written 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.


Job Requisition ID:  226455
Location:  Rockville
Career Level:  B - Recent University Graduate(<1 year of experien
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday.

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Job Type : Full-Time
Education Level : Bachelors Degree
Experience Level : Entry Level
Job Function : ""
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