Quality Assurance Administrative Associate

About the role

We are seeking a Quality Assurance Administrative Associate who will be responsible for supporting our quality assurance team onsite in our Parsippany, NJ office. The right candidate will have some experience with regulatory processes, possess strong interpersonal skills, be very detail oriented, organized, and work well independently while being part of a larger team.

Canfield Imaging Systems is the world-leading developer of specialized photographic systems for medical practices, institutions, research organizations, and pharmaceutical suppliers. Canfield Imaging Systems is a division of Canfield Scientific, Inc., the largest provider of photographic documentation systems and services for pharmaceutical research.

Responsibilities

• Schedule management for both the team and individual events (meetings, audits, vendors, etc.) within the quality team as well as with the facility coordinators
• Provide meeting support, including coordination of materials, team members, and taking meeting minutes
• Support the QA team with deliverables and timelines, email responses, coordination and routing of training, patent updates, audit activities, and trackers/spreadsheets identifying urgent request escalation as warranted
• Coordinate with the production team to ensure all administrative deliverables have been met
• Assist with the creation, maintenance, and archiving of employee training binders
• Distribute and maintain study-specific training to applicable employees, routing reminders to the assigned team members, sharing documentation for review/signature, and following up on project status
• Assist with vendor qualifications
• Research changes to applicable regulations and present findings for review

Requirements

• Associate degree or at least 3 years demonstrated work experience
• Knowledgeable of the regulatory process (FDA, ISO 13485 and 9001)
• Proficient with Microsoft Office
• Demonstrated ability to multitask with strong organizational and time management skills
• Professional demeanor with strong communication skills both verbal and written