IT Quality Engineer

Are you an IT quality leader with strong QMS, NDA readiness and vendor audit experience?

If you are an IT quality leader with a proven track record with FDA regulations, QMS, GxP, NDA, SLC, CSV and change controls, we want to hear from you. SQA is looking for an experienced IT Quality Engineer to work with a biotechnology client seeking New Drug Application (NDA) approval.

In this fast-paced environment, the ideal candidate will design and support all compliance activities required for new drug approval and commercialization. If you thrive in small company environments, this is an opportunity to act as a key facilitator in driving fulfillment of IT and corporate strategic goals.

While supporting development of the IT systems QA methodology, the qualified candidate will have extensive experience with:

  • Overall QMS support
  • Developing/supporting procedures (SOP’s) and work instructions
  • Guiding IT, IT Validation, and business stakeholders for all CSV deliverables
  • Ensuring CSV deliverables (e.g., PQ validation scripts and protocols) adhere to regulations and internal Quality requirements
  • Reviewing IT systems project plans, identifying issues, and providing hands on support to Project Managers and BA’s on quality and validation requirements
  • Supporting change control processes and implementation of computerized systems
  • Vendor audits for vendor qualification or re-qualification
  • Internal review and audits of CSV program as needed

Job ID: 1809-5629
SQA is an equal opportunity employer and supports workforce diversity.