QA Associate

Responsibilities:

Reviewing executed batch records and equivalent production documents, as well as assisting in closure of batch record review backlog

Supporting day-to-day operations such as room release and reviewing manufacturing and equipment changeover activities

Reviewing quality events, including deviations, lab investigations, CAPAs, and change controls

Supporting document reviews, including but not limited to SOPs, COAs, protocols, and reports

Working closely with both Manufacturing, Quality Control, and Facilities teams in any quality matter

Key qualifications: 

Undergrad or master’s degree in biological sciences, analytical chemistry, chemical engineering

1-2 years experience in GMP industry (junior level)- Any experience in biotechnology industry is preferred but not required

Strong critical thinking skills when working on new procedures or process improvements