Quality Systems Training and Consulting Associate (Part-Time)

Overview Quality Systems Training and Consulting Associate (Part-Time) PathWise, Inc. is a world-class training firm that improves compliance and quality systems for client companies. Our clients include the FDA as well as many top medical device, pharmaceutical and biologics organizations. PathWise provides instructor-led and web-based training programs. The PathWise system of learning is designed to support the most critical factors for organizational and individual success within the Life Science industry. Our focus is on improving all aspects of quality system and maintaining compliance with regulatory bodies. PathWise is a values-based organization with a unique, family-like culture. We are a 100% virtual organization. The Quality Systems Trainer and Consulting Associate will report directly to the Head of Operations. They will provide both support to the Master Quality Systems Trainer while contributing industry expertise to support the development and continuous improvement of PathWise courses. Travel Travel Requirements: This role is remote but will require 25% travel to client sites to deliver trainings. Responsibilities Act as a regulatory consultant by monitoring evolving pharmaceutical, medical device, and biologic guidelines and recommending timely updates to PathWise course content. Create and publish white papers to the PathWise website. Write and develop training material as needed. Deliver exceptional classroom training and coaching to class sizes of 15 to 25 participants Provide individual coaching on skills and behaviors from classroom delivery Maintain and support IACET Continuing Education Accreditation initiatives and requirements. Strategically responds and works with Executive team to carry out company initiatives Manage and maintain online filing system through SharePoint. Qualifications Education and Experience: Bachelor’s degree in Life Science or equivalent. 10 or more years’ experience in a biologic, pharmaceutical, or medical device organization. Experience in delivering classroom training for a broad audience base. Competency to clearly present and discuss GxP regulations and Quality System requirements using adult learning principals. Language Ability: Employee is able to read and understand at a highly technical and proficient level. The employee follows instructions, both verbal and written, and communicates effectively with fellow employees. Computer and Technical Skills: Microsoft Suite (Outlook, Word, SharePoint, Excel, PowerPoint, Visio, and Project) Experience in some or all of the following topics: CAPA and Investigations, Change Control, Quality Risk Management, Good Documentation Practices, Technical Writing, Quality System Regulations, Good Manufacturing Practices, Good Clinical Practices, Good Laboratory Practices, Validation, Root Cause Analysis Understand adult learning principles Understand and apply FDA and other country regulatory requirements Experience in effectively planning and organizing a classroom environment Proficient in technical and procedure writing Knowledge of classroom and exercise facilitation techniques Possess Project Management skills Present to a range of audiences ranging from floor level manufacturing, clinical personnel, laboratory staff up to high level management Manage travel when faced with short deadlines #J-18808-Ljbffr