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Quality Specialist, Computer Systems Validation

MilliporeSigma - Rockville, MD

Posted 16 days ago

3 people have applied

Job Description

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 theCustoms Auditteam as part of the Quality Assurance departmentincludes 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 toauditing computer systemvalidationas well as otherdocumentationwithin theCustoms Auditsteam 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,
    Annex11andotherregulatory 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)
  • Collaboratewith global,cross-functionalteamsto accomplish company objectives and team goals including but not limited to on-time completion of systemgo-livesand enhancements
  • Manage continuous improvement efforts for the computerized systems validation program
  • Provide support forGxPregulatory inspections as needed, including acting as subject matter expert for QualityGxPcomputervalidationtopics
  • Provide Computer Validation tester/reviewer training asneeded
  • 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 Controlrecords
  • Provide guidance and/or training for Quality Specialists


You Are:



  • Bachelor's degree in a scientific (i.e. Biology, Chemistry, etc.)or a technical (i.e. Engineering, Computer Science, etc.)discipline
  • 5+ years' experience invalidation, QA validation, validation testeror related technicalfield withinapharmaceutical, life sciences or biotechnology environment

Preferred Qualifications:

  • Excellent technical writing skills and ability to document all work in anaccurate and timely manner
  • Proficient knowledge of FDA and EUcomputer systemsvalidation andassociatedregulations (cGMP, GLP, ICH, GAMP, DI, Part11)
  • Acts ethicallyand 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 implementschange on local and global scales


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!


Apply and find more information at

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

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