Quality Assurance Engineer

QRC Group is seeking an experienced Quality Assurance Engineer to provide oversight and quality leadership for a major Grade D Manufacturing Environment project at a sterile combination drug/device manufacturing facility.

This individual will serve as the Quality Assurance Engineer for the project, supporting the implementation of a Central Dust Extraction system, Grade D manufacturing area and suite build-out, and equipment relocation and validation activities. The selected candidate will review, approve, and sign validation and quality documentation while ensuring compliance with applicable cGMP regulations, data integrity requirements, and site quality standards.

Key Responsibilities

• Provide Quality Assurance oversight for the Grade D Manufacturing Environment project, including:
  • Central Dust Extraction System implementation
    
  • Grade D area and suite construction activities
    
  • Equipment relocation and validation efforts
    
• Review, approve, and sign validation protocols, reports, and manufacturing documentation on behalf of Quality Assurance.
  
• Serve as the primary QA resource for technical and compliance-related questions from Engineering, Manufacturing, Validation, and Project teams.
  
• Support environmental monitoring (EM), bioburden, contamination-control, and cleanroom compliance programs for Grade C and Grade D classified areas.
  
• Review and approve cleaning validation documentation, including master plans, protocols, sampling strategies, and acceptance criteria.
  
• Support deviation investigations, root cause analyses, CAPA development, and quality risk assessments.
  
• Ensure compliance with cGMP requirements, company procedures, and data integrity principles (ALCOA+).
  
• Participate in facility qualification, equipment qualification, and validation activities.
  
• Provide QA support during audits, inspections, and regulatory readiness activities.
  
• Collaborate cross-functionally to ensure project milestones are achieved while maintaining the highest quality standards.