Jobs at Sekisui Diagnostics, LLC

Qualified Person responsible for ensuring biologic drug substance batches comply with UK/EU GMP, certify and release batches, support inspections/audits, maintain MIA(IMP), provide regulatory oversight, deliver cGMP training, mentor future QPs, and support continuous improvement and supplier/internal audits.

Perform quality control testing of raw materials, in-process samples, and finished goods; manage proficiency surveys and certifications; establish assay specifications and SOPs; investigate lab issues, review product workbooks for release, and support equipment calibration and lab administration tasks including OOS, NC, Change Controls and CAPA closure.