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The IT compliance analyst is a critical role to our compliance program. This position assists with internal and external audits by our pharmaceutical clients, College of American Pathologists (CAP), New York State, International Standards Organization (ISO), Internal and External Quality Assurance teams (including Medical Quality Assurance - MQA).

This position will be a Subject Matter Expert (SME) on Quest applications and to help with interpreting Federal and State Regulations. The SME will assist with the Laboratory Automation and Standardization conversions for Quest Diagnostics.

As a Scrum SME, assist with the conversion from the old Quest Process Execution Waterfall Process (PEP) to an Agile process. As a Digital Analyst embedded within our Scrum teams, you will be responsible for driving data-informed decision-making across all phases of our digital products' lifecycle, from strategy development to execution and ongoing operations.

Working closely with product managers, developers, and other technology and business stakeholders, you will leverage your analytical expertise to optimize user experiences, drive business growth, and ensure continuous improvement.

• Be a point of contact for IT and assist on all internal and external audits.
  • Assist with Pharmaceutical audits.
  • Assist with internal and external College of American Pathologist (CAP), New York State, Medical Operations and Quality (MOQ), International Standards Organization (ISO)
• Monitor activities of assigned IT areas to ensure compliance with internal policies and procedures including monthly, quarterly, and annual account and activity reviews.
• Identify observations and manage remediation tasks through to closure while adhering to strict deadlines.
• Conduct security control tests of operating effectiveness activities - Archer Sarbanes Oxley Testing (SOX)
  • Handle/requests from external auditors Ernst and Young (E&Y)
  • Handle/requests from external auditors Price Waterhouse Cooper (PwC)
• Manage Archer Request for Service (RFS) and Exemptions (EXC)
• Support IT Compliance during the following review meetings:
  • Security Review Board (SRB) Meetings for Clinical Trials implications
  • Architecture Review Board (ARB) Meetings for Clinical Trials implications
  • Change Review Board meetings (CAB)
  • Q-Suite Change Control and Release Lock meetings
  • Quality Improvement Forum
  • Safety Committee Team member for IT
  • Business Continuity
  • Periodic Management Review Meeting
• Work collaboratively with Security Compliance and Legal teams to identify and manage privacy, data protection risks, and compliance requirements to help meet stakeholder expectations.
• Make broad recommendations on improving compliance related processes and/or procedures as it pertains to the IT department and Identify opportunities for security compliance control automation.
• Partner with management, business teams, and/or data team to implement solutions.
• Laboratory Standardization Transformation (LabOS)
• Working understanding of how compliance works with cloud-native technology.
• Demonstrated experience and familiarity with security control frameworks (e.g. SOX, SOC 2, ISO, NIST, etc.)
• Familiarity with common compliance standards (HIPAA, SOX, SOC2, GxP, NIST, and/or ISO) and experience working directly with internal or external auditors for at least one of the listed standards.
• Manage/Support Annual Disaster Recovery Exercises
• Manage the Software Validation Repository in SmartSolve:
• Triage Change Management issues and provide recommendations.
• MediaLab Administration
• Conduct thorough analysis of digital data using various tools and methodologies to inform sprint planning, backlog refinement, and prioritization discussions.
• Develop and maintain a backlog of analytics-related tasks and initiatives, ensuring alignment with the product roadmap and strategic objectives.
• Assist in the implementation and validation of analytics tracking solutions to ensure accurate data collection and measurement of key metrics.
• Collaborate with QA analysts to validate data integrity and troubleshoot any issues related to tracking implementation or data discrepancies.
• Provide regular updates and reports on key performance metrics, trends, and insights to stakeholders, including product owners, senior management, and other cross-functional teams.
• Act as a subject matter expert on digital analytics best practices tools, and methodologies within the Scrum team, and proactively share knowledge and insights with team members.

Education Required: BS/BA degree required in Computer Science/Information Systems or related field.

Work Experience:

• Minimum 1-2 years' FDA Regulatory knowledge (Clinical Laboratory)
• Minimum 1-2 years' experience work with Quality Management Systems (QMS) tools and Information Technology (IT) security compliance programs
• At least 2 years' experience working in an Agile framework with digital products
• Experience in coaching, mentoring and/or training other team members

Knowledge:

• Customer Experience Management
• Design Thinking
• Business/Digital Analysis
• Agile
• Healthcare or clinical lab industry knowledge essential
• International Standards Organization (ISO) knowledge (9001, 15189, 13485)

Skills:

• Change management
• Strong analytical and critical thinking skills
• Beyond the typical communications skills, an ability to tell a story is a must have "what does the data tell us?"
• Ability to build strong and trusted relationships
• Collaborate with others for optimal results
• Ability to work independently and drive for results
• Business process mapping (BPM) skills beneficial

Preferred Technical Training/Certifications:

• Rally, Jira, Agile, Scrum certification

While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies.Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.

Quest Diagnostics is an equal employment opportunity employer. Our policy is to recruit, hire and promote qualified individuals without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any other status protected by state or local law. Quest Diagnostics observes minimum age requirements established by federal, state and/or local laws, and will ask an applicant for verification when deemed necessary.