About the Opportunity
Our client is seeking an experienced Quality Assurance Specialist to support quality operations within a regulated biotechnology manufacturing environment. This role will play a key part in ensuring product quality, regulatory compliance, and the effectiveness of the Quality Management System supporting in vitro diagnostic (IVD) products. This position is ideal for a quality professional with strong experience in batch record review, product release, ISO 13485 compliance, and quality event management.
Responsibilities

+ Perform review of batch records, QC records, raw material inspection records, calibration records, and related manufacturing documentation.

+ Support lot release activities for raw materials and finished products.

+ Prepare and review Certificates of Analysis as needed.

+ Review and approve quality events including NCRs, CAPAs, complaints, and deviations.

+ Support investigations, root cause analys...