Robert Elms Email & Phone Number

Andover, Ma

Support remediation effort in test method and process validation at client company.

Ogden, Ut

• As part of internal remediation effort, manage biocompatibility project for existing packaging of • As As part of internal remediation effort, manage biocompatibility project for existing packaging of hemodialysis compoundsFor development of new product, responsible for design of toxicological tests for a new material and biocompatibility testing of the new product which includes significant management and interaction with contract research organization (CRO)

Ann Arbor, Mi

As part of internal remediation effort, support client on development and execution of internal Test Method and Process validationsAs part of supplier remediation effort, support client on development and execution of process validations for critical supplier of PCBAs

Developed and implemented concepts, designs, processes and procedures for manufacture of two new productsLed initial development of documentation for manufacturing, design control and quality systems and ongoing development and revision of systems in growing dynamic environmentInitiated design control activities for companyInvolved in validation activity: including equipment, process, materials and productDesigned and implemented processes to enhance internal and external customer satisfactionDeveloped and managed departmental budgets for operationsDeveloped and implemented enhanced processes resulting in 30% reduction in product costsDeveloped and provided technical review of development, manufacturing, packaging, validation, testing and distribution documentationWrote and updated manufacturing risk analysisInvolved in product risk analysis reviews and updatesSupported continuous improvement through involvement in CAPAs, NCMRs, product complaints and design changes

Managed Operations in transfer and launch of 10 new products resulting in 10% growthDeveloped and managed budgets for operations, manufacturing, materials and engineeringImplemented and validated automated filling/capping equipment resulting in improved internal and external customer service and cost reduction of 15%Managed design control activities for operations and manufacturing

San Marcos, Ca

Project manager for development of diagnostic test cartridge utilizing DNA amplification technology, and developed separation technology for productDeveloped and implemented scale-up of synthesis process of polyurethane bladder for an implanted medical device, and validated process which led to FDA approval of the processDesigned, implemented and validated drying process for HIV test manufacturer resulting in 50% reduction in costs and 20% reduction in scrapSupplied expertise for companies with 483 deficiencies for validation of processes and equipment

Master Of Business Administration (Mba), Business

Bachelor'S Degree, Chemistry