Managed and assured over 40 suppliers and contract manufacturers to be compliant to Cytiva QMS & regulatory requirements, ensuring quality in bioprocess assemblies used by biopharmaceutical customers· Led highly visible investigation, documenting and managing open quality events and change notifications serving critical cell and gene therapy client· Audited suppliers for ISO and QMS compliance, identifying corrective actions and highlighting opportunities for continues improvement by reviewing documentation, processes, and data collection methodologies· Leveraged product lifecycle management expertise to train and provide consultation to colleagues for dozens of procedures, projects and quality management activities· Identified critical gaps in internal processes and remedied them through developing revised frameworks· Created, revised, and reviewed QMS documentation such as work instructions, deviations, specifications, and action plans

Drove three business critical projects to completion through Cytiva QMS by utilizing cross functional collaboration· Prevented production line down of assemblies for COVID-19 vaccine development by rapid implementation of design changes· Managed and executed engineering changes for 100s of bioprocessing products including material and design change verification, mold validation, and supplier product analysis and qualification· Identified and remedied major pain points in custom and global design change process through corrective actions implemented at both Cytiva and associated suppliers, saving over $500,000· Planned and executed verification testing for improving existing product designs to reduce scrap and failure rates by over 50%

Led development and execution of experiments for verification and functional testing of consumable products. Wrote reports analyzing resulting data, performing risk assessment, and provide next steps to increase visibility.Utilized Solidworks and Creo to design product parts, modify assemblies, and edit product documentationAuthored test protocols, technical and product specifications and other product documentation within the GE quality systems.

Designed a biodegradable scaffold elastomer for mesenchymal stem cell delivery for bladder tissue regeneration· Optimized processes to improve polymer yield by 40% while ensuring a consistent quality· Synthesized, purified, characterized, tested, and studied biocompatibility for baboon bladder implementation· Delivered four scaffolds to partner lab in Feinberg School of Medicine for suturing into baboon bladder tissue

Prepare samplesSorting and Organization of samples and equipmentOther duties given by Mentor