IT Compliance Specialist (Contract, San Diego, CA)

Description:

SQA Solution is looking for an IT Compliance Specialist in San Diego, CA. This is a 1+ months contract (remote/part-time).

Skills

 

  • 2 to 5 years of hands-on experience.
  • Run a 21 CFR Part 11/Annex 11 remediation program or project.
  • Risk-based understanding of 21 CFR Part 11/Annex 11 as it applies to software applications.
  • Should have a basic understanding of:
  • Veeva Vault (QualityDocs, eTMF, RIM)
  • IRMS
  • Argus
  • SAS
  • Tracelink
  • SLIMstat
  • Needs to understand IT SDLC and SaaS.
  • Excellent communication skills must be able to communicate with Business Owners and talk them through the understanding of the regulations and the need for remediation. 


This person can be remote but must be able to initiate a remote meeting (WebEx, GoToMeeting, etc.).
This may not be an 8 hour a day, 5 days a week role depending on the availability of the Business Owners, audit support, remediation effort, etc. The project could run 200 to 600 hours total.

Deliverables per system for 8 systems:

  • Completed assessment form (the form is already created)
  • Remediation plan (if needed)
  • Remediation (if needed)
  • Summary report (if needed)

Skills:

remediation, sas, argus, regulatory compliance, compliance audit, compliance engineering, irms, veeva vault, fda compliance, compliance specialist, cfr part, tracelink, slimstat
Please review all application instructions before applying.

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