Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

Analyst, IT Governance

Job Code: #802
Job Type: Direct Hire
Salary: $17.00 - $18.00/hour
Job Location: Lincolnshire, IL
Posted 6 days ago

Job Description

Job Title:  Analyst, Process & QA Compliance

Salary:  $72,000 - $76,000

Job Overview:  The Analyst, Process & QA Compliance is responsible for leading the strategy, review, submission and creation, when applicable, of product design and development documentation for Customer Systems & Innovations products to meet and maintain internal RA/QA and FDA requirements. This includes, but it not limited to, building and reviewing requirement and planning documentation, supporting the test strategy and plans, ensuring design reviews for verification and validation testing are completed according to plan and working closely with defined team members in the creation and/or execution of testing for software updates and releases.

This role provides guidance and consultation, as directed by the Supervisor, Systems – Cybersecurity & QA Compliance, as an independent reviewer to team members to ensure approved Customer Systems & Innovations and QA processes are followed, while also ensuring documentation prepared by others team members is complete, comprehensive and follows all approved standards.

As directed by the Supervisor, Systems Cybersecurity & QA Compliance, this role supports the implementation and monitoring of cybersecurity & QA policies, processes and requirements for all groups with Corporate Systems & Innovation. Supports efforts to maintain the independent 3rd party HITRUST certification of Caresphere WS.  Also supports the plan of a HITRUST roadmap for the other applications in Corporate Systems & Innovations to ensure cybersecurity compliance.

Essential Duties and Responsibilities:

  • Implements and ensures QA/Customer Systems & Innovations approved processes are followed to maintain RA/QA and cybersecurity compliance.
  • Leads, coordinates and participates in effort for product design and development documentation for Customer Systems & Innovations teams.
  • Coordinates and participates with team leaders to generate product requirements, product master plan, design review, validation summary report and hazard and risk analysis documentation for Customer Systems & Innovations teams.
  • Serves as an independent reviewer for Customer Systems & Innovations medium and low risk products, as assigned by the Supervisor, Systems – Cybersecurity & QA Compliance.
  • Collaborates and interacts with various Corporate Systems & Innovation (Architecture, Development, Systems/Interface Engineering, Test & Release, Operations) in collecting data/information pertaining to QA documentation and cybersecurity for QA and HIPAA/HITRUST compliance.
  • Will support continuous monitoring of HITRUST security controls to ensure that they continue to be implemented correctly, operating as intended and producing the desired outcome with respect for meeting the cybersecurity requirements for assigned HITRUST pre/post certified systems.
  • Partners with 3rd Party software development teams to ensure consistent processes are followed for product design & development documentation and secure coding related HIPAA/HITRUST requirements.
  • Consult group leads on their cybersecurity and QA process, policy and compliance. Also oversees consistent implementation of technology strategy on digital workflow process systems such as Jira and Confluence to ensure compliance.
  • Other duties as assigned.
  • Bachelor's degree and 3 years required experience QA and/or Security Compliance, QA Software Engineer, Application Testing Processes
  • Bachelor’s degree with a specialization in Business Administration or Human Resources preferred.
  • Working knowledge of software testing strategies.
  • Working knowledge of ISO framework for Product Design & Development Processes for software applications including cloud-based solutions.
  • Working knowledge of FDA regulations.
  • Working knowledge of Agile methodology.
  • Proven ability to work under stress in emergencies with flexibility to handle multiple high-pressure situations simultaneously.
  • Leadership abilities including effective knowledge sharing, conflict resolution, facilitation of open discussions, fairness and displaying appropriate levels of assertiveness.
  • High critical thinking skills to evaluate alternatives and present solutions that are consistent with business objectives and strategy.
  • Must demonstrate initiative and effective independent decision-making skills.
  • Office Suite (Word, Excel, PowerPoint, Outlook), Atlassian Suite (Jira, Confluence, Zephyr), Tricentis qTest Suite.
  • Flexibility/adaptability, effective communications and ability to work with individuals at all levels of organization. Professional conduct necessary at all times even under stressful conditions. Ability to communicate concisely and interact with auditors.