Katherine Parker Email & Phone Number

Dallas/Fort Worth Area

Tucson, Arizona Area

• Divisional project risk management representative, developing and refining best practices across multiple business units including schedule risk analysis and risk reporting pilots• Partner with Lifecycle leader to support Advanced Staining Lifecycle, including facilitating Lifecycle Team meetings• Provide cross-functional and software development project management support to platform development projects• Support deployment of new planning software (Planisware) through training delivery and process development• Leadership Team and Programming Lead for Roche Women in Leadership (RWIL) Tucson chapter• Supported multiple Advanced Staining Assay Development product development and design control update projects• Managed project schedule & risks, analyzed critical path and proactively mitigated potential gaps/bottlenecks/delays• Coordinated and managed budget with business leader, finance partner, and functional leads• Managed project team meetings, driving completion of team deliverables, action items, and decisions• Encouraged use of best practices and continuous improvement through modeling behavior, regular briefings at functional meetings, and coaching/mentoring of coworkers

Atlanta, Ga

• Worked on product development teams to ensure that products complied with applicable regulations, including reviewing risk management documents, 510(k) submissions, and technical files for ISO certification• Developed and executed raw material, in-process, and final product quality inspections• Performed internal audits to ensure compliance to quality system and regulations; worked with engineers on corrective actions and followed them through until completion• Maintained records, including batch records, material inspections, and supplier management documentation• Ensured proper training for all new hires, performing training as appropriate and maintaining training files• Managed controlled documentation system and developed quality system documentation

Atlanta, Ga

• Facilitated interactions between internal teams, field sales representatives, and physicians throughout the full product life cycle to ensure successful launch of two new product lines and additional product line extensionso Worked with development engineering leads to ensure timelines remained accurateo Clarified milestones and critical paths and identified challenges and potential delays• Contributed to marketing strategy and branding, especially product positioning and training• Developed sales and marketing materials, including managing marketing collateral• Provided field support, including supporting surgeries in the operating room, training sales agents and providing product demonstrations, coordinating symposiums and seminars, and managing/working tradeshows

Baton Rouge, Louisiana

• Collaborated with Executive Management and Department Managers to develop timelines and milestones for all projects, especially for presentations to Board of Directors and potential investors or customers• Supported Chief Operating Officer (COO) with daily operations functions and strategic portfolio management• Developed Production Schedule in Microsoft Project and ensured its execution by acting as liaison between Quality Assurance, Quality Control, Manufacturing, Pharmaceutical Engineering, and the COO• Worked with COO and Department Managers to ensure facility and procedures comply with Current Good Manufacturing Practices• Managed electronic controlled documentation system and training requirements• Reviewed and provided comments on the quality of documents and took necessary steps to correct any deficiencies

Baton Rouge, Louisiana

• Managed team of 3-4, successfully coordinating 5 production runs through transfer to Downstream Processing• Collaborated with Executive Management and Department Managers to develop timelines and milestones for all projects, especially for presentations to Board of Directors and potential investors or customers• Implemented and managed Train the Trainer program for the entire company• Developed Production Run Plans, including Microsoft Project schedule, and ensured its execution by acting as liaison between Quality Assurance, Quality Control, Manufacturing, and Pharmaceutical Engineering• Performed product/process development and optimization and developed Batch Records and Standard Operating Procedures for processes transferred from Research & Development to Manufacturing

Birmingham, Alabama

• Developed new product using Microsoft Project for time management and scheduling• Ensured compliance with FDA regulations, especially CFR 21 Part 820• Documented customer complaints and CAPAs; facilitated necessary actions until each was resolved• Streamlined production through process optimization• Trained personnel on all new or updated manufacturing processes• Maintained and repaired process equipment, especially through mechanical and electrical repairs

Biomedical Engineering Department

MSU Biological Engineering ProgramProject Title: "Immediate-early gene expression changes in porcine aortic valve cells subjected to cyclic strain"Physics Department

Project Title: “Automatic masking and phase unwrapping of DENSE cardiac motion images in humans"

Particle Engineering Research CenterProject Title: "Investigation of bioactive ceramic materials: effects of particle size in bioglass doped sol-gels"

Master Of Science, Biomedical Engineering

Activities and Societies: Biomedical Engineering Society – Secretary, Intramurals – Basketball, Football, Softball, Dodgeball.

Bachelor Of Science, Biological Engineering

Activities and Societies: Chi Omega Fraternity (Phi Delta Chapter) – Secretary, Asst Secretary, Student Association Executive Board –.