Quality Assurance Training Coordinator

Responsibilities

• Administer and maintain the GMP program and Learning Management System; experience with Veeva is preferred but not required.
• Maintain up-to-date knowledge on all applicable regulatory guidelines and regulations, and develop training programs to ensure employees are equipped to succeed on cGMPs and other regulations.
• Participate in compliance evaluation of regulated activities within pharmaceutical development and cGMP manufacturing.
• Develop and update GMP training materials for new-hires, existing employees, contractors and visitors; assist with group training.
• Coordinate and/or provide annual GMP and GDP training.
• Administer training program schedules on standard operating procedures (SOPs), GMP concepts and organizational policies, when required.
• Manage employee training program and maintain metrics/reports; review all training files periodically.
• Assign and track required training based on employee roles, curricula, job functions, and departmental requirements.
• Monitor training completion and overdue training and communicate/escalate as appropriate.
• Inform management of deviations from regulations and cGMP and assist in determining appropriate solutions while verifying that assigned actions have been implemented.
• Collaborate with Quality Assurance, Manufacturing, Quality Control, Facilities, Supply Chain and other functions.
• Maintain employee training records and ensure training documentation is complete, accurate, attributable, and readily retrievable.
• Participate in learning and training to be competent in above functions.
• Generate and review training metrics, including overdue training and on-time completion.
• Support investigations and CAPAs related to training deficiencies or training-system issues.
• Assist with periodic review of training curricula and employee training assignments to ensure continued appropriateness.
• Support inspection readiness by retrieving training records and responding to training-related documentation requests, as well as acting as SME for training during inspections.
• Other duties as assigned.

Requirements and Preferred Qualifications

• Bachelor's degree, preferably in life sciences or technical field, or equivalent combination of education and relevant experience.
• 2+ years of professional experience in a training or developmental capacity.
• Experience in an electronic training system such as Veeva Training Vault preferred.
• Experience within biopharmaceutical industry is highly preferred along with a demonstrated understanding of cGXPs.
• Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking.
• Highly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure.
• Demonstrated ability to prioritize and manage multiple projects simultaneously.
• Demonstrated ability to work effectively with many different types of personalities at all levels of the organization.
• Excellent interpersonal, collaborative and stakeholder management skills.
• Excellent communication skills (written/verbal).