Quality Assurance Engineer

Job Title: Junior Quality Assurance Associate Location: Pennsylvania — Onsite Employment Type: Contract (W2 Only) Experience: 0–3 Years Job Summary 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. Key Responsibilities 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 Required Qualifications 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 Preferred Skills 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 TrackWise, Veeva, MasterControl, or other eQMS platforms is preferred