Patti Smith Email & Phone Number

Golden Valley, Minnesota, United States

Responsible for end-to-end clinical data management activities on diverse scope clinical studies. FDA 21CFR 812, GCP, GCDMP

Golden Valley, Minnesota, United States

Responsible for end-to-end clinical data management activities on diverse scope clinical studies. FDA 21CFR 812, GCP, GCDMP

Golden Valley, Minnesota

Responsible for internal and supplier quality system audits. Coordinate document control, training, audit schedules, and CAPA. External audit host for external client and regulatory audits. ISO 9001:2015, ISO 17025:2017, FDA 21CFR 58, FDA 21CFR 812, GCP, GLP - Implemented Grand Avenue Software (electronic quality management system) document control and training modules into a paper-based system from concept to go-live in 7 weeks - Created management processes for nonconformance and training management in paper-based system - Provided on-site continuous improvement support for GLP facility - Awarded 2 promotions in 3 years; Internal Compliance Specialist to Senior Compliance Specialist to current

Plymouth, Mn

Responsible for integrating a new or recently acquired Abbott location into an established corporate quality system. The position will assist with the planning, and will lead the execution of the integration activities. - Decreased backlog of out-dated procedures from previous integration efforts by 40% within 1st year in support of Global Clean-up project. - Drove the integration of the SJM Rogers site to 90% completion within 1st year. - Awarded Silver Medal of Distinction for leadership in creating and executing integration strategy - Awarded Silver Medal of Distinction as a key contributor on a short notice high-profile regulatory project

St. Jude Medical, 5050 Nathan Lane N, Plymouth Mn

Responsible for managing the document translation project during site shutdown preparation. Collaborated with other functions/sites to create/maintain a list of project objectives, communicated progress status, and created Change Requests to release documents in Windchill.

New Hope Mn

Responsible for performing laboratory investigations in the Quality Control laboratories. Designed and implemented initiatives for the improved performance of laboratory operations and compliance.- LeanSigma Yellow Belt certification achieved April 2013.- Decreased Laboratory investigations by 56% by presenting root cause analysis and investigative feedback.- Improved staff morale and engagement as demonstrated by a 5% increase in Just-Do-It activities by implementing feedback survey and participation reward system.

New Hope Mn

New position responsible for audits of material and component suppliers, contract laboratories, and internal processes and systems; supported supplier selection and maintenance through Supplier Quality Management (SQM).- Key Contributor in development of SQM process and Supplier Risk Management evaluations.- Led site training and participated in rollout of Audit Information Manager in TrackWise to support global auditing function.- Provided compliance training to pre-commercial QA team members after Quality Re-organization to help distribute workload.

New Hope Mn

Responsible for leadership, guidance and activity coordination within the Technical Auditing team. - Facilitated improvements in the calibration system including updating SOPs, collaborating with external vendors to improve the process, and providing input for overall system improvement. Initiated certification process with iNARTE for the Certified Laboratory Auditor program (ISO 17025).- Led implementation for ER/ES in Empower CDS. Updated SOPs and customized Reviewer training to support the electronic review of chromatography data.- Key Contributor in Empower Custom Calculations team providing structure and guidance to ensure compliance and productivity enhancements would be gained.- Reduced time spent searching for documents by 80% by creating centralized location for document storage for in-process finished goods.

New Hope Mn

New position responsible for technical review of testing documentation including wet chemistry and various instrumentation (HPLC, GC, UPLC, particle size, AA, UV, etc.). Position created to improve laboratory compliance.- Developed the position from concept to established role. Created database measurement tool to facilitate review tracking and trending processes.- Improved Right-First-Time by 60% by implementing 8 compliance systems in 14 months.- Provided tracking and follow-up for audit responses, SOP annual review and document updates.- Developed a USP Change Control process that was adopted by corporate Change Control system.- Technology leader for productivity and compliance enhancements including development of audit tracking database, validation of Excel spreadsheet, departmental SharePoint site administrator and research of Electronic method execution system (ELN, LIMS, or LES).- Coordinated the Quality Control portion in the SOP restructure project. Provided tracking and follow-up to ensure tasks were completed on schedule.- Key contributor of various documentation improvement teams. Teams worked to resolve internal documentation inconsistencies and external global updates to bring manufacturing documentation requirements in-line with laboratory standard.- Earned the “Beaker Award” for outstanding customer service and teamwork.

Mendota Heights, Mn

Responsible for wet chemistry testing including ICP-OES, automatic titrators, and microwave digestion system. Additional role involved creation and maintenance of product manufacturing specifications, coordination of alternate raw material approval process, performed GLP in-life audits, and safety committee member. - Supervised wet chemistry laboratory staff; laboratory output included competitive product breakdown, municipal water analysis, and titration analysis.- Investigated and purchased a second ICP-OES, developed and supervised instrument validation, performed method development specific for new instrument.- Coordinated and planned the testing of 13,000 water samples from around the country.- Identified LIMS updates/corrections to enhance productivity, provided method/SOP training, and data quality review.