Teams at Sekisui Diagnostics, LLC

Provides independent administrative support to the Engineering and Maintenance department. Administers the Computerized Maintenance Management System, manages work schedules and requests, coordinates preventative maintenance and statutory inspections, collects contractor documentation, maintains contractor accreditations and insurance records, supports contractor approval processes, and logs and files capital approval forms. Requires strong organization, planning, attention to detail, Microsoft Office skills, cGMP knowledge, and CMMS experience.

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.