GRC Analyst

Part-time - Entry Level

Remote - Silver Spring, MD

About the position

The GRC Analyst position at DataBridge involves supporting the compliance profile of DataBridge Sites, particularly in relation to IT systems and regulatory standards. This part-time role offers opportunities for rapid growth and advancement within a company that specializes in compliant hosting for health and life science sectors, as well as government agencies.

Responsibilities

• Supporting compliance regulations and standards pertinent to IT systems (e.g. HIPAA, 21 CFR Part 11, GxP, Annex 11, NIST 800-53).
• Administering DataBridge's electronic Quality Management System.
• Documenting, reviewing, and managing compliance activities (e.g. Change Management, Incident handling, System Qualification/Validation, Corrective and Preventive Actions, Document Control, User Training).
• Developing test plans to verify IT controls.
• Reviewing and updating DataBridge policies and procedures consistent with DataBridge's compliance control set.
• Participating in internal and external audits.
• Other duties as assigned.

Requirements

• 2+ years' experience with risk management, quality management and/or audits of commercial IT systems.
• Bachelor's degree in related field preferred, two-year degree and/or relevant certification may be considered.
• Excellent technical writing and communications skills.
• Ability to learn and work independently.
• Ability to manage projects independently and clearly communicate status to management.
• Experience in a regulated environment is strongly preferred (e.g. HIPAA/HITECH, 21 CFR 820, 21 CFR 210/211, 21 CFR Part 11, FedRAMP, NIST 800-53, NIST 800-171, etc).
• Computer system validation experience is helpful (e.g. GAMP).

Nice-to-haves

• IT Compliance
• Quality Assurance
• Quality System
• Risk Management
• Audits
• GAMP
• HIPAA
• NIST
• GMP
• Part 11
• GxP
• FedRAMP
• Computerized Systems Validation
• CAPA
• CSV
• FDA

Benefits

• Opportunities for advancement