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IT Compliance Analyst

  • Location: Somerset, NJ
  • Start Date: 1/13/2020
  • Job ID: 20-00024
  • Posting Date: 1/13/2020
  • Job Type: Contract
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Perform detailed IT Compliance tasks to ensure high-quality, complete deliverables and GxP (Good X Practices) compliance prior to implementation or release, including:
Develop and/or enhance comprehensive quality assurance process to ensure that each deliverable is traceable to project specifications and other deliverables
Review deliverable content and format for accuracy, completeness, accessibility
Frequent and detailed interaction with Software Quality Assurance, Business Systems Analysts, Application Development and Project Management teams to ensure that each deliverable meets or exceeds client expectations
Carry out validation, and documentation preparation for FDA 21 CFR Part 11 assessments for internal applications as well as off-the-shelf software
Perform internal mock audits and external vendor audits
Develop Installation Qualifications (IQ) / Occupational Qualifications (OQ) / Performance Qualifications (PQ) and protocols
Create Risk Assessment, Validation Test Plan and Validation Summary Report
Track the collection of and completeness of all Validation documentation deliverables required for compliance and audits
Work with the IT and Regulatory teams on SOP development
Provide guidance to internal departments in system validation, HIPAA security and FDA 21 CFR Part 11 requirements
Prepare for and represent team in internal, client and FDA audits

The above duties are meant to be representative of the position and not all-inclusive.

Bachelor's Degree in related field or equivalent related work experience
1 - 3 years' experience in a Computer Systems Validation (CSV) environment either as a validation or compliance subject matter expert
Knowledge of FDA's validation requirements and 21 CFR-Part 11 requirements is required
Experience in IT Audit, IT Risk Management or IT Compliance is a plus
Exposure to pharmaceutical industry data and applications is a plus

Excellent organizational; verbal and written communication skills
Ability to work independently with minimal supervision, and as effective team member
Strong analytical skills to Client, analyze and resolve problems
Detail-oriented mathematical, proofreading, and grammatical skills
Posted by Geoff Sarro