Quality Specialist, Computer Systems Validation

9/1/2021

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.    

 

Your Role:

The scope of this position within the Customs Audit team as part of the Quality Assurance department includes impact to a range of important customer, operational, project or service activities within own team and other related teams or even the area. Guides and influences peers or management regarding technical issues and challenges. Affects the results within own discipline with own contributions and contributes to the technical direction or even the strategic direction and operational decision making in the field of specialization.  

 

The individual performs a variety of tasks related to auditing computer system validation as well as other documentation within the Customs Audits team as part of the Quality Assurance.  Responsibilities will include but are not limited to:

  • Review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements
  • Review validation documentation – such as user requirements, functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix requirements, deviations, validation summary reports, decommissioning reports and system use documentation (system admin, user admin procedures)
  • Collaborate with global, cross-functional teams to accomplish company objectives and team goals including but not limited to on-time completion of system go-lives and enhancements
  • Manage continuous improvement efforts for the computerized systems validation program
  • Provide support for GxP regulatory inspections as needed, including acting as subject matter expert for Quality GxP computer validation topics 
  • Provide Computer Validation tester/reviewer training as needed 
  • Ensure archival of validation documentation – both paper and electronic
  • Monitor industry, new/revised regulations around SDLC and CSV and guidance for impact to the organization related to computer system validation
  • Review and approve deviations / OOS records and CAPAs
  • Review and approve change control (GCC) and IT Change Control records
  • Provide guidance and/or training for Quality Specialists

 

Who You Are:
Minimum Qualifications:

  • Bachelor’s degree in a scientific (i.e. Biology, Chemistry, etc.) or a technical (i.e. Engineering, Computer Science, etc.) discipline
  • 5+ years' experience in validation, QA validation, validation tester or related technical field within a pharmaceutical, life sciences or biotechnology environment 

 

Preferred Qualifications:

  • Excellent technical writing skills and ability to document all work in an accurate and timely manner
  • Proficient knowledge of FDA and EU computer systems validation and associated regulations (cGMP, GLP, ICH, GAMP, DI, Part11)  
  • Acts ethically and ensures quality of own work and that of others
  • Collaborates with various teams to identify and implement improvements
  • Applies technology to drive digitalization, improve quality and increase customer value
  • Works with agility and drives and implements change on local and global scales

 

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:  222906
Location:  Rockville
Career Level:  D - Professional (4-9 years)
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, Masters
Experience Level : Mid to Senior Level
Job Function : General
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