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Sr. IT Compliance Analyst (QMS)
Ref No.: 18-11811
Location: San Diego, California
This person will be responsible for performing System Risk Classifications, Gap Assessments and Remediation of legacy non-Product software applications.

Tasks and responsibilities:

• Participate on cross-functional teams of IT, Business Analysts, Quality and business SMEs to understand/document systems intended use and perform System Risk Classifications.
• Review existing system validation documentation (User/Functional requirements, testing, traceability, etc.) and assess for completeness per Client's System Life Cycle (SLC).
• Develop system remediation documentation (e.g. requirements updates, validation plans, testing, etc.).
• Oversee the execution of remediation efforts.
• Write reports that summarize the validation results.
• Support the change control process by following established Client policies.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Client's Quality Management System per FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Perform other duties & projects as assigned.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

• Preferred educational background:
• BS degree or equivalent in IT.

• Preferred experiential background:
• Minimum of three to five years related experience in software validation or software quality assurance (medical device / diagnostics preferred).
• Experience with GAMP5 SDLC methodology including system risk classification, gap/risk assessments, validation and testing.
• Working knowledge of 21CFR Part 11 / EU Annex 11 requirements.
• Experience and understanding of systems security including access controls and data integrity.