PathWise · 5 days ago
Quality Systems Training and Consulting Associate (Part-Time)
United States
Full-time, Part-time
Hybrid
Senior Level, Lead/Staff
10+ years expPathWise, Inc. is a world-class training firm that improves compliance and quality systems for client companies. The Quality Systems Trainer and Consulting Associate will support the Master Quality Systems Trainer and contribute industry expertise to enhance PathWise courses while delivering training and maintaining compliance with regulatory bodies.
ComplianceMedicalQuality AssuranceTraining
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
Qualification
Required
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 principles
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
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
Adept in auditing
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
Company
PathWise
PathWise is a life science company that provides virtual instructor-led training and compliance training services.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Nathan Conover
President and CEO
Company data provided by crunchbase