Auditing, Best Practices, Biotech and Pharmaceutical, Business Growth, Business Processes, Center For Drug Evaluation and Research (CDER), Change Management, Cloud Computing, Continuous Improvement, Corrective Action, Customer Acquisition, Customer Support/Service, Customer/Client Research, Documentation, FDA (Food and Drug Administration), Knowledge Transfer, Leadership, Metrics, Onboarding, Online Training, Operational Strategy, Process Improvement, Product Demonstration, Proposal Development, Quality Management, Risk Management, Salesforce.com, Standard Operating Procedures (SOP), Systems Administration/Management, Systems Maintenance, Technical Presentation, Train-the-Trainer, Training Program, Training/Teaching, Training/Teaching Curriculum, Training/Teaching Materials, User Documentation, Vendor/Supplier Management, eLearning
To acquire the advantage, Zolon PCS is seeking a Training Specialist. This program will replace multiple decentralized and legacy quality management environments with a single, enterprise-wide platform that supports quality, compliance, training, audits, risk management, equipment management, supplier management, and corrective action processes across FDA Centers and Offices. The solution will support FDA organizations, including the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Human Food Program (HFP), Office of the Chief Scientist (OCS), Office of Inspections and Investigations (OII), and other FDA quality organizations.
Job Description:
Develop, maintain, and deliver role-based training programs supporting implementation, deployment, operations, and maintenance (O&M) of ComplianceQuest and Salesforce GovCloud solutions.
Create training materials including user guides, standard operating procedures (SOPs), quick reference guides, job aids, eLearning modules, instructor-led training content, and train-the-trainer curricula.
Conduct instructor-led, virtual, and self-paced training sessions for end users, administrators, managers, and executive stakeholders.
Support organizational change management (OCM) activities by developing communication plans, stakeholder engagement strategies, adoption metrics, and readiness assessments.
Coordinate onboarding, refresher training, office hours, user support sessions, and knowledge transfer activities to promote successful adoption and sustained system utilization.
Monitor user adoption, collect user feedback, identify knowledge gaps, and recommend training improvements to enhance user effectiveness and operational performance.
Support go-live readiness activities, deployment planning, post-implementation stabilization, and transition-to-operations efforts.
Collaborate with business stakeholders, quality teams, system administrators, developers, and project leadership to ensure training content reflects approved business processes and system functionality.
Ensure training materials, knowledge assets, and user documentation remain current and aligned with FDA, quality management, and organizational requirements.
Provide subject matter expertise for proposal development, technical solutioning, customer demonstrations, oral presentations, technical exchanges, and capability briefings.
Contribute lessons learned, best practices, reusable training assets, and organizational knowledge artifacts to support continuous improvement and business growth.
Support development of innovative training and adoption solutions based on experience gained through the FDA Cloud QMS Program and collaborate with corporate leadership to expand ComplianceQuest, Salesforce GovCloud, and Quality Management service offerings.
Requirements:
Minimum 5 years of training and change-management experience.
Prior FDA experience desired.
Experience developing role-based training programs.
Experience supporting enterprise Salesforce implementations.
Experience developing instructor-led and online training content.
Experience supporting organizational change management activities.
Experience supporting go-live readiness and user adoption initiatives.
Training certifications desirable.
Bachelor's degree desired.
Clearance: Ability to obtain Public Trust tier 2
Location: White Oak, Maryland (Hybrid)