Quality Specialist

Evergen • Alachua, FL

10d • Onsite

About The Position

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ.

Requirements

• Bachelor's Degree
• 0-3 years of experience in quality assurance, systems, regulatory affairs, or other relevant experience within a regulated industry such as tissue, medical device, or pharmaceutical
• Additional experience may substitute for education requirement
• Lead Auditor Certification
• Excellent verbal and written communication
• Microsoft Office Suite
• Quality Management System (QMS) software
• Presentation
• Auditing
• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
• Onsite: Office environment with assigned workstation
• Remote positions only: Home office environment with minimum distractions

Responsibilities

• Supports quality system compliance with the appropriate internal and external regulatory requirements and maintains awareness of the overall regulatory landscape
• Collects, analyzes, and reports data elements to demonstrate conformity and maintains the effectiveness of the quality management system with a high degree of accuracy
• Contributes to the company process improvement initiatives that impact quality systems and works collaboratively with cross-functional stakeholders to ensure compliance of processes and procedures within the quality management system
• Supports audit and inspection preparation, resolution of audit and inspection findings, and coordinates with auditing groups and inspectors through all stages of the audits
• Applies for and maintains the company’s quality management system licensure including registration and recertification to ensure all licenses stay current
• Acts as a subject matter expert during internal and third-party audits for responsible processes
• Supports all elements of audit planning, execution, closeout, and follow-up with a high level of customer service
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level