Document Control Training Manager

Nivagen Pharmaceuticals • Sacramento, CA

11h • $90,000 - $140,000 • Hybrid

About The Position

The Document Control & Training Manager will support the development, delivery, and maintenance of training programs related to document control, ensuring compliance with industry standards like ISO, FDA, GMP, or GDP. They ensure that employees understand and follow document control processes, systems, and regulatory requirements, while also supporting audits and quality management initiatives.

The role involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards. Occasional travel may be required for audits, supplier evaluations, or training. Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius).

Requirements

• Bachelor’s degree or equivalent combination of education and experience.
• 3–5 years in a regulated industry; preferred experience in project management, training, quality systems, or related fields.
• Familiarity with regulatory standards (ISO, FDA, GMP, GDP).
• Strong presentation, communication, and facilitation skills.
• Problem-solving and proactive approach to challenges.
• Excellent organization and attention to detail.
• Proficiency in Microsoft Office and Learning Management Systems (LMS).
• Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius).

Nice To Haves

• Experience in project management
• Experience in training
• Experience in quality systems

Responsibilities

• Design and create training materials for QMS and document control processes; deliver instructor-led and virtual sessions across departments and sites.
• Provide onboarding training for new hires on document management and QMS procedures; support change initiatives by coaching and training impacted teams.
• Evaluate training outcomes, update content, and ensure alignment with industry standards.
• Maintain training records, track completion and competency, and provide documentation for audits to demonstrate compliance.
• Create/add curriculum assignments in the training system, generate reports, and distribute training results.
• Partner with other departments to provide first-line training support and improve training programs.
• Assist in the maintenance and continual improvement of the QMS, ensuring compliance with GMP, FDA, EMA, and other relevant regulatory standards.
• Manage QMS documentation, including the creation, revision, and archival of SOPs, quality manuals, and other controlled documents.
• Coordinate the implementation of change controls to ensure systematic evaluation and documentation of changes affecting the QMS.
• Analyze quality data from various sources, including non-conformances, deviations, and CAPAs, to identify trends and areas for improvement.
• Generate detailed reports on QMS performance metrics, providing insights and recommendations to senior management.
• Monitor key performance indicators (KPIs) related to quality, such as defect rates, audit findings, and CAPA completion times.
• Assist in planning, conducting, and documenting internal audits to ensure compliance with the QMS and regulatory requirements.
• Support external audits conducted by regulatory agencies and clients, preparing necessary documentation and providing responses to audit findings.
• Track and follow up on audit findings to ensure timely and effective resolution, including the implementation of corrective and preventive actions.
• Stay current with changes in regulatory requirements and industry standards, ensuring that the QMS is updated accordingly.
• Conduct periodic reviews of QMS documentation and processes to verify ongoing compliance with applicable regulations.
• Participate in risk assessments and contribute to the development of risk mitigation strategies within the QMS framework.
• Identify opportunities for improving quality processes and the overall QMS, recommending and implementing enhancements to increase efficiency and effectiveness.
• Lead or participate in root cause analysis for quality issues, ensuring that appropriate corrective and preventive actions are identified, implemented, and monitored for effectiveness.
• Provide training and support to staff on QMS processes, regulatory requirements, and quality improvement initiatives.
• Work closely with cross-functional teams, including Production, Quality Control, Regulatory Affairs, and Supply Chain, to ensure alignment on quality objectives and regulatory compliance.
• Collaborate with the Supplier Quality Management team to ensure that suppliers meet the company’s quality standards and that the supply chain complies with GMP.
• Communicate effectively with internal stakeholders to provide updates on QMS activities, audit results, and continuous improvement initiatives.
• Review batch production records for completeness, accuracy, and compliance before product release, ensuring that all quality standards are met.
• Ensure proper control, accessibility, and regular review of all QMS documents, maintaining a high standard of documentation accuracy and compliance.

Benefits

• Medical, dental, and vision coverage
• Paid time off plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree