As a Quality Assurance Specialist III/IV at Celldex Therapeutics, you will use your life sciences industry experience to support various Good Manufacturing Practices (GMP) and Good Laboratory Practice (GLP) operations. You’ll work at both our Needham and Fall River, MA sites plus occasionally travel overnight for business.
You’ll work with our team to review and audit complex documents and data (batch records, GMP and GLP protocols, GLP and GMP data); ensure compliance to Quality System procedures; and assure compliance to specs and standards by performing quality audits.
You’ll also provide Quality support for external and internal manufacturing, and clinical product distribution. This support includes employee training; revising SOPs and related manufacturing documents; assisting with investigations related to manufactured products; and performing internal/external audits and Contract Manufacturing Organization (CMO) site visits.