Quality Assurance Engineer

Job Title:
Junior Quality Assurance Associate

Employment Type: Contract (W2 Only)

Experience: 0–3 Years

We are seeking a detail-oriented Junior Quality Assurance Associate to support quality systems, documentation review, and compliance activities within a GMP-regulated pharmaceutical, biotechnology, or medical device environment.

The ideal candidate will assist with quality documentation, deviations, CAPA, change controls, and audit-readiness activities while collaborating with Manufacturing, Quality Control, Validation, and Engineering teams.

• Review and maintain SOPs, batch records, quality records, and controlled documents
• Support deviation, non-conformance, and quality investigation activities
• Assist with CAPA initiation, tracking, documentation, and closure
• Support change control activities and quality impact assessments
• Review manufacturing and laboratory documentation for accuracy and compliance
• Maintain quality records within electronic Quality Management Systems (eQMS)
• Support internal audits and regulatory inspection readiness activities
• Assist with employee training documentation and quality metrics
  
  Collaborate with Manufacturing, QC, Validation, Engineering, and Regulatory teams
• Ensure compliance with GMP/cGMP, FDA regulations, and company quality procedures

• Bachelor's degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering, or a related field
• 0–3 years of Quality Assurance, Quality Control, or regulated industry experience
• Basic understanding of GMP/cGMP and Quality Management Systems
• Strong attention to detail and documentation skills
• Good analytical, organizational, and communication abilities

• Familiarity with CAPA, deviations, change controls, and document control
• Exposure to pharmaceutical, biotechnology, or medical device environments
• Knowledge of FDA regulations and ISO 13485 is a plus
• Familiarity with Track Wise, Veeva, Master Control, or other eQMS platforms is preferred