Training and GXP Documentation Specialist

The Training & GxP Documentation Specialist plays a critical role in ensuring compliance with Good Manufacturing Practices (GMP) and GxP documentation standards. This role is responsible for managing controlled documentation, overseeing training programs, and ensuring data integrity across multiple departments. The ideal candidate will have a strong background in Training Management Systems (TMS), Quality Management Systems (QMS), CAPA investigations, and compliance-driven documentation processes.

Key Responsibilities:

Training & Documentation Management:

• Oversee daily training and documentation tasks ensuring compliance with GxP and data integrity principles.
• Act as Training SME, developing and assessing training curricula, monitoring materials, and evaluating effectiveness.
• Conduct training impact assessments and create Role-Based Training Matrices.
• Generate training metrics, develop job aids/workflows, and conduct team training sessions.

Content & Document Control:

• Manage electronic document management systems (EDMS) such as Veeva, ClientDocs, ensuring document accuracy and compliance.
• Oversee controlled documents (SOPs, forms, training materials) and ensure proper periodic reviews and updates.
• Ensure change controls and CAPA-related documentation are accurately maintained and updated.

Digital Solutions & SharePoint Management:

• Establish and manage SharePoint sites for enhanced team communication and collaboration.
• Identify and implement digital solutions to replace paper-based processes and optimize workflow efficiency.
• Evaluate and recommend electronic solutions to streamline training and documentation processes.

Quality Compliance & CAPA Management:

• Perform quality investigations, including root cause analysis (RCA) and Corrective and Preventive Actions (CAPA).
• Ensure timely completion of investigations and compliance with regulatory documentation standards.
• Provide support for deviation management, change controls, and compliance reporting.

Process Improvement & Collaboration:

• Identify opportunities for process optimization and implement best practices.
• Work cross-functionally to drive continuous improvement initiatives and support compliance efforts.
• Facilitate training sessions and workshops to promote a culture of excellence.

Must-Have Qualifications & Skills:

• Experience with Training Management Systems (TMS) such as SuccessFactors, ComplianceWire.
• Proficiency in Quality Management Systems (QMS) and EDMS tools such as Veeva, ClientDocs.
• Strong knowledge of GMP, GxP documentation, and Data Integrity principles.
• Experience with CAPA investigations, deviation writing, and change control management.
• Expertise in SharePoint management; experience with AI-driven tools is a plus.
• High attention to detail with strong organizational and time-management skills.
• Ability to work independently in a fast-paced, compliance-driven environment.
• Excellent communication and collaboration skills, with the ability to negotiate and act as a mediator between functional areas.
• Proficiency in Microsoft Office Suite (Excel, Word, Visio, PowerPoint, SharePoint, Outlook).

Why Join Us?

• Be part of a high-impact team ensuring compliance and excellence in GxP documentation and training.
• Opportunity to work with cutting-edge digital solutions and enhance operational efficiencies.
• Engage in cross-functional collaboration and contribute to continuous improvement initiatives.