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Forge Biologics is a biotechnology company focused on enabling access to life-changing gene therapies, particularly AAV manufacturing and gene therapy development. The company operates a state-of-the-art 200,000-square-foot cGMP facility in Columbus, Ohio.
As Technical Training Specialist within the GMP Quality Training team, you will serve as a subject matter expert in training system administration and compliance reporting. Reporting to the Senior Technical Training Manager, you will own the daily operations of the training management system (Veeva Vault), ensuring accuracy in assignments, curricula, records, and compliance metrics.
Key responsibilities include:
• Independently manage the administration of the training management system, ensuring accuracy of training assignments, curricula, user records, and completion data.
• Oversee and implement updates related to new documents, role changes, and departmental requests in full alignment with GMP/GDP requirements and internal SOPs.
• Act as a primary point of contact for troubleshooting and provide subject matter expertise to end users, resolving complex inquiries and system issues.
• Lead routine and ad-hoc data integrity reviews, resolve discrepancies, and coordinate the testing and implementation of system enhancements or configuration changes.
• Ensure all training activities are documented and maintained in strict compliance with regulatory requirements; serve as a lead resource during audits and inspections by preparing records and demonstrating system functionality; partner with Quality leadership on inspection readiness.
• Lead the development of training reports, dashboards, and trend analyses that inform leadership decisions and support regulatory inspection-readiness.
• Deliver training system instruction to employees at all levels and facilitate GMP/GDP training sessions.
• Drive continuous improvement initiatives that strengthen compliance, learner engagement, and training effectiveness.
The role combines system administration, regulatory compliance, training delivery, and data analytics in a regulated biotech manufacturing environment.
Requirements: The posting excerpt provided does not include a dedicated requirements section. Specific qualifications, years of experience, education, certifications, or domain background requirements were not included in the text excerpt supplied.
