Quality Assurance Associate II

Responsibilities

• Assist in batch record review and disposition for clinical product manufacturing, including label issuance, product packaging, and shipping activities.
• Support the issuance, tracking, and archiving of controlled documentation in compliance with GxP (GLP/GCP/GMP) regulations. 
• Maintain and manage controlled records, including batch/test records, logs, reports, and quality management documentation. 
• Assist in preparing materials for internal audits and ensuring documentation readiness for regulatory inspections. 
• Help process and track training records to ensure company-wide GxP compliance. 
• Participate in the review and release of incoming materials in accordance with company standards. 
• Support controlled label issuance, including inventory tracking and updating lot numbers. 
• Collaborate with senior team members to improve and implement quality management systems and training programs. 
• Assist in preparing reports and documentation related to deviations, corrective actions, and change controls. 
• Support the maintenance and management of documentation systems, both manual and electronic, ensuring timely and accurate record-keeping. 
• Perform additional quality assurance tasks as assigned. 

Requirements

• Bachelor’s degree in a relevant field (e.g., Biology, Biotechnology, or related discipline) or equivalent experience. 
• 0-3 years of experience in a regulated environment (e.g., cGMP, GLP, GCP). 
• Familiarity with regulatory standards such as 21 CFR 210 and 211, ICH, ISO9001, and FDA guidelines preferred. 
• Strong attention to detail and excellent organizational skills for managing documentation and records. 
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with database systems. 
• Strong written and verbal communication skills for effective collaboration and reporting. 
• Ability to work independently and as part of a team in a dynamic, fast-paced environment. 
• Comfortable gowning and working in classified areas as required. 

Work Environment / Physical Demands

• Primarily office-based with occasional time in GMP cleanroom environments for documentation and oversight tasks. 
• Requires prolonged periods of computer use for documentation and record management, and gowning for cleanroom work. 
• May involve lifting materials or equipment up to 20 pounds. 
• Ability to navigate office and classified GMP environments for quality assurance activities.