Quality Assurance Specialist III, QA Training

Role Summary

Quality Assurance Specialist III, QA Training at Wave Life Sciences. Responsible for the oversight and maintenance of Wave’s GxP Training program, partnering with functional leaders to develop and maintain effective training that promotes employee competency and compliance readiness. This is an in-person role onsite at the Lexington facility requiring a minimum of 4 days onsite.

Responsibilities

• Manage the training program
• Creation and revision of role-based training curricula to align with functional responsibilities
• Manage onboarding of new employees by facilitating Quality onboarding training, verifying account creation and assigning curricula in Wave‚Äôs Learning Management System
• Support the creation and revision of Training related SOPs, work instructions, training materials in collaboration with Subject Matter Experts (SMEs)
• Provide training and support for employees on the use of the Learning Management System (LMS)
• Support the development of training materials such as quizzes, instructor-led courses, and on-the-job training
• Facilitate GxP training for employees, as needed
• Oversight of training compliance across all departments, publish periodic training reports, and escalate compliance issues to management
• Collaborate cross-functionally to support LMS upgrades, vendor releases, and change management
• Manage or support the timely closure of relevant Quality System records
• Identify and participate in initiatives to improve the training program, LMS and training content
• Support development of Quality Management Review content to measure the health and effectiveness of the training program
• Support audits and regulatory authority inspections by providing training reports/documentation or other assigned tasks
• Oversight and timely response of training related inquiries
• Other duties as assigned
• Ensure timely completion of annual training review by providing support to functional leads and escalating issues to management
• Oversight of employees‚Äô CVs and job descriptions to ensure compliance
• Ensure timely generation and review of content for Annual GMP refresher training

Qualifications

• Bachelor‚Äôs degree with a minimum of 4 years of related or transferable experience in the pharmaceutical or biotechnology industry, preferably in Quality Assurance/Training
• Experience in the administration of electronic learning management systems
• Veeva and/or ComplianceWire is preferred
• Experience in training program administration
• Experience working in a GMP manufacturing facility

Skills

• Knowledge of GxP and Quality Systems principles with respect to US, EU, and other relevant regulatory guidance
• Superior organization skills with ability to manage competing priorities and meet deadlines
• Demonstrated ability to train GXP personnel one-on-one and in groups
• Works independently with minimal supervision
• Excellent team player with strong written and verbal communication skills
• Ability to work cross-functionally while providing excellent customer service
• Knowledge of instructional design principles for adult learning
• Champions continuous process improvement
• Proficient with MS Office Suite including Word, Excel and PowerPoint