Jonathan Ringham

Developed work instructions for operating SAP TIME S/4HANA ERP and led format and content harmonization for documentation related to SAP TIME S/4.

Investigated QC deviation OOS events and quality trends for CAR-T therapeutics and implemented CAPA to address process, procedure, and planning gaps.

Ensured timely batch release through risk assessment and NC/CAPA investigations for CAR-T deviations, applying Root Cause Analysis methods including Six Ms, 5 Whys, and fishbone/Ishikawa diagrams.

Supported nonconformance and CAPA investigation as a backup investigation writer/owner, including harmonizing acquired CAR-T product documentation and maintaining document alignment with vendor specifications.

Performed Six Sigma Agile format revision to the Trackwise system and migrated SOPs, job aids, and forms into a new hierarchy, including converting URS to performance qualification test plans and SOPs.

Drafted Quality Management System documents for governance of medical device CMOs, including policy, deviation, CAPA, and change control management systems, and updated FDA-based documents to align with ISO regulatory guidelines.

Prepared QC incoming SOPs and a method library for a new site and improved document lifecycle by introducing decoupled attachments, managed through GDocs EDMS and tracked in Trackwise.

Collaborated with DeltaV SMEs to establish functional specifications for fermentation plant expansion and supported data migration and document merger activities across systems, including EDMS-based review and approvals.

Identified supply chain documents requiring GxP governance, revised SOPs and distribution procedures to establish Amgen as the primary supplier, and supported international planning and formal IP approval via EDMS.

Compiled Annual Product Quality Reviews from multiple manufacturing sites into global APQRs, reviewed for format and consistency, and harmonized templates to support GMP/GDP document execution.

Compiled SME data into APRs for OTC medications, ensuring deviations, investigations, CAPAs, and APR action items were complete for the calendar year and improving executive visibility through graphical updates to the APR template.

Maintained a GxP document library using version control and periodic review, led GMP training assignments and orientations, and supported FDA audits by retrieving controlled document and training records.

Earned a Bachelor of Arts in Molecular, Cellular, and Developmental Biology from the University of Colorado at Boulder.