Sr. IT Compliance Analyst in San Diego, CA at APEX Systems

Date Posted: 8/2/2018

Job Snapshot

Job Description

Job #:  872946

Our client is a leading healthcare management and IT consulting firm, delivering integrated management and technology solutions to various healthcare setting with the goal of improving the quality, efficiency, and effectiveness of healthcare

Overview:

This role will be responsible for performing System Risk Classifications, Gap Assessments and Remediation of legacy Non-Product software apps. 

Responsibilities:

Collaborate and perform on cross-functional teams of IT, Business Analysts, Quality and Business SMEs to understand and document system use and perform System Risk Classifications.

Review existing system validation documentation (User/Functional requirements, testing, traceability, etc.) and assess for completeness per clients System Life Cycle.

Develop system remediation documentation such as requirements updates, validation plans and testing.

Oversee the execution of remediation efforts.

Write reports that summarize the validation results.

Support the change control process by following established policies.

Carries out duties in compliance with established business policies.

Demonstrates commitment to the development, implementation and effectiveness of 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.

Education:

* BS degree or equivalent in IT.

Preferred experience:

Min. 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.

 

 

 

 

 

 

 

 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.

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