Quality Assurance Associate

Job Responsibilities

• Provide Quality oversight on the manufacturing floor to ensure processes meet established quality and compliance standards
• Review and approve GMP documentation, including batch records and operational logs
• Partner with Manufacturing and Operations teams to support investigations related to process or equipment deviations
• Support batch record review, material disposition, and product release activities
• Assess deviations to determine scope, impact, and appropriate containment or escalation actions
• Contribute to deviation investigations using root cause analysis and risk-based approaches
• Promote a strong culture of safety, quality, and compliance
• Ensure data integrity through accurate documentation in paper-based and electronic systems
• Analyze trends and process variability to support continuous improvement initiatives
• Manage multiple priorities effectively in a fast-paced manufacturing environment

• Bachelor’s degree required (or equivalent experience); scientific discipline preferred
• 2+ years of experience in a regulated manufacturing environment in Quality and/or Operations
• Working knowledge of GMPs, quality systems, and deviation management
  
  Strong understanding of Good Documentation Practices
• Excellent written and verbal communication skills
• Comfortable working with computerized manufacturing or operational systems

2nd or 3rd shift