Quality Assurance Specialist, I

Role: Quality Assurance technician responsible for batch record review, product release, and final product inspection in a biopharma manufacturing setting. Main objectives include ensuring GMP compliance, timely batch disposition, and supporting process improvements. Responsibilities involve batch record review, label issuance, archiving, final product inspection within ISO 7 clean rooms, and supporting day-to-day operations under supervision. Qualifications: High School diploma/GED with 2+ years or Bachelors with 0-1 years relevant biotech/pharma experience; basic GMP knowledge. Preferred skills include strong communication, organization, proficiency in MS Word/Excel, and experience with electronic batch records, ERP, and Quality Management Systems like TrackWise or Veeva. High-value details: Manufacturing of advanced cell therapies for sports medicine and burn care, including products like MACI, Epicel, and Nexobrid; involves aseptic processing in ISO 7 environments; on-site role in Burlington, MA, with some work at Cambridge during training; schedule Tuesday–Saturday with physical requirements supporting gowning into classified clean rooms, lifting up to 30 lbs, and supporting rotating holiday and weekend coverage.