Quality Compliance Specialist II - Training & Document Control

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. We are seeking a Quality Systems Specialist II to support our site Quality Systems organization, with a primary focus on the Training program and additional responsibilities supporting Document Control.

This role will support both the administration and execution of the site training program. In addition to managing training assignments, curricula, records, and compliance activities, the Quality Systems Specialist II will serve as a trainer for designated Quality System and site processes, delivering instructor‑led training and helping employees understand and effectively apply procedural requirements. The position will also be cross‑trained to support Document Control activities, providing flexible coverage based on workload, business priorities, and team needs.

• Support administration of the site Training program, including training assignments, curricula, records, reporting, and follow‑up.
• Serve as a qualified trainer for designated Quality System and site processes, delivering instructor‑led, group, and individual training as appropriate.
• Develop, maintain, and improve training materials, presentations, job aids, and other learning resources.
• Partner with process owners and subject matter experts to ensure training content accurately reflects procedural and regulatory requirements.
• Support onboarding and role‑based training for new and existing employees.
• Monitor training compliance and proactively follow up on overdue, incomplete, or otherwise non‑compliant training.
• Investigate and resolve training‑related issues, including assignment, curriculum, documentation, and system discrepancies.
• Support training‑related audit and inspection readiness, including retrieval and review of training records.
• Identify opportunities to improve training effectiveness, employee understanding, and the overall user experience of the Training program.
• Support Agile document workflows, including processing and routing document and change orders.
• Review documentation for completeness and compliance with applicable procedures prior to routing or approval.
• Provide Agile system support and assist users with document and change‑control activities.
• Support document administration, data maintenance, and record management activities.
• Provide backup coverage for Document Control and other Quality Systems activities as needed.
• Support Quality System metrics, data quality reviews, reporting, and process improvement initiatives.

• Bachelor’s degree or equivalent combination of education and relevant experience.
• Experience in Quality Systems, Training, Document Control, or a related function within a regulated environment.
• Experience working within an electronic document management, learning management, or Quality Management System.
• Strong communication and interpersonal skills, with the ability to explain requirements clearly to employees with varying levels of experience.
• Comfort and demonstrated ability presenting information, facilitating training, and engaging groups of learners.
• Strong organizational skills and attention to detail, with the ability to manage multiple priorities and follow activities through completion.
• Ability to work independently while collaborating effectively across functions.

• Experience in the medical device, pharmaceutical, biotechnology, or other highly regulated industry.
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