GxP Computer Systems Administrator

3 weeks ago


Rockville, Maryland, United States 2072 BioReliance Corporation Full time

We are seeking a highly motivated GxP Computer Systems Administrator to join our team at 2072 BioReliance Corporation. As a key member of our Transformation Office, you will play a critical role in maintaining regulatory compliance of GxP computer systems throughout their lifecycle.

This position requires a strong understanding of GxP regulations and guidelines, including GAMP 5, US Code of Federal Regs. 21 CFR Part 11 and Part 211, Eudralex Volume 4, Annex 11 & Annex 15, ICH Q7, Q8, Q9 & Q10. The ideal candidate will have a Bachelor of Science/IT (B.S.) or Bachelor of Arts (B.A.) degree in science or technical area and at least 3 years' experience in a regulated environment.

This role offers a competitive salary range of $70,500 - $118,300 per year, as well as benefits such as medical, vision, and dental insurance, life insurance, disability insurance, a 401(k) matching program, paid time off, and paid holidays. We value diversity, equity, and inclusion in our workplace.

Job Responsibilities
  • Perform administration tasks for various GxP systems and associated software in a regulated environment following defined procedures.
  • Develop and implement processes to ensure Data Integrity assurance, focusing on accuracy, reliability, and security across organizational systems.

Preferred Qualifications:

  • Minimum 3 years' experience in a regulated environment.
  • Advanced knowledge of FDA and EU regulations (cGMP, GLP).


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