Agiloft & ComplianceWire Support Associate in California at OmegaHires

Position Summary
We are seeking a detail-oriented Agiloft & ComplianceWire Support Associate to provide functional and operational support for training, compliance, and content review workflows within a regulated life sciences environment. This onshore role will support end users, maintain system integrity, and ensure compliance with GxP and regulatory requirements across Agiloft (MLR/PRC workflow) and ComplianceWire (LMS).

Key Responsibilities
AgileLoft (MLR/PRC) Support

• Provide day-to-day support for AgileLoft users, including content routing, workflow management, and issue resolution
• Assist with setup and maintenance of review workflows, user roles, and permissions
• Troubleshoot submission, approval, and annotation issues within MLR processes
• Support content lifecycle management, including versioning, tagging, and archiving
• Partner with Marketing, Medical, and Legal teams to ensure timely review cycle completion

ComplianceWire (LMS) Support

• Administer and maintain ComplianceWire training assignments, curricula, and user records
• Support onboarding/offboarding activities and training compliance tracking
• Troubleshoot user access, training completion, and reporting issues
• Generate and distribute compliance reports for audits and internal stakeholders
• Ensure training records align with regulatory and audit requirements (GxP, FDA, etc.)

Cross-Platform & Operational Support

• Serve as first-line support for system-related inquiries and escalate issues as needed
• Maintain system documentation, SOPs, and job aids
• Support data integrity, validation activities, and audit readiness efforts
• Collaborate with IT, QA, and vendors for system enhancements and issue resolution
• Monitor system performance and proactively identify improvement opportunities

Required Qualifications

• Bachelor’s degree in Life Sciences, Business, IT, or related field
• 2+ years of experience supporting AgileLoft, ComplianceWire, or similar platforms (MLR/PRC tools and LMS systems)
• Strong understanding of content review processes and training compliance in regulated environments
• Experience with user support, ticketing systems, and issue troubleshooting
• Proficiency in Excel and reporting tools
• Strong attention to detail and documentation skills
• Ability to work PST hours and collaborate with cross-functional teams

Preferred Qualifications

• Experience in pharmaceutical, biotech, or medical device industries
• Familiarity with GxP, FDA regulations, and audit readiness processes
• Experience with Veeva PromoMats, Veeva Vault, or other MLR systems
• Knowledge of data governance and compliance frameworks
• Exposure to validation processes (CSV) or system release management

Key Competencies

• Strong problem-solving and troubleshooting skills
• Effective stakeholder communication and support mindset
• High attention to compliance and data accuracy
• Ability to manage multiple tasks in a fast-paced environment
• Process-oriented with a continuous improvement mindset