Quality Assurance Specialist - Junior

Job Title: Quality Assurance Specialist - Junior
Job Location: Bridgewater, NJ
Job Duration: 6 Months

Responsibilities:

• Support daily administration, maintenance, configuration, and operation of the ComplianceWire Learning Management System (LMS).
• Manage LMS user profiles, user groups, training items, curricula, and training assignments.
• Maintain quality systems training records and documentation in compliance with company policies and applicable regulatory standards.
• Support employees and business teams with LMS administration, training assignments, and related issues.
• Generate, download, and analyze standard, custom, scheduled, and ad hoc LMS reports.
• Track training completion, system usage, and compliance metrics.
• Assist with internal audits, regulatory inspections, and training documentation.
• Identify and resolve LMS-related issues and support improvements to training processes.

Must Haves:

• Bachelor's degree or equivalent combination of education and experience.
• 0-1 year of experience in pharmaceutical, biotechnology, or medical device environments, preferably in quality or regulatory functions.
• 0-1 year of Learning Management System (LMS) administration experience.
• Ability to manage training records, assignments, user accounts, and LMS reporting.
• Strong organizational, communication, and problem-solving skills.
• Ability to work in a hybrid environment and coordinate with onsite training teams.

Nice to Haves:

• Hands-on experience with ComplianceWire LMS.
• LMS Administrator certification or equivalent demonstrated expertise.
• Familiarity with FDA regulations, including 21 CFR 211 and 21 CFR 820, and ISO 13485.
• Experience supporting quality management systems (QMS), training compliance, or regulated documentation.
• Experience supporting internal audits or regulatory inspections.