NATIONAL SALES DIRECTOR LORI ANN SWISHER Phone:

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1 Curriculum Vitae NATIONAL SALES DIRECTOR LORI ANN SWISHER Phone: Summary of Qualifications Lori has over 25 years of technical experience in the quality control and regulatory compliance within the device, pharmaceutical, and biologics industries. She has extensive experience in QA/QC, domestic and international regulatory compliance, customer service with clients as well as suppliers, project management, internal and external consultation and auditing, and regulatory document preparation. She has a strong management background of both quality assurance and laboratory personnel. Lori possesses additional business strengths in organizational skills, team and quality system management, business development and sales. Professional Experience NATIONAL SALES DIRECTOR, LexaMed, Ltd. Toledo, OH Responsible for maintenance of existing company based business, as well as the development of new business opportunities to include consulting, laboratory and testing services for the Medical Device, Pharmaceutical and Biotech industries. Expand the company customer base with new business by identifying, qualifying and selling our services to companies that have current or future needs. Follow-up on all leads in a timely manner. Responsible to execute sales strategy / sales planning. Stay current with testing processes and information relevant to LexaMed that enhances our competitive position and profitability. Attend industry association meetings for ongoing learning and industry networking. Participate and work trade shows to generate leads for future business. Attend outside sales and professional training to enhance skill set. Page 1 of 5

2 MANAGER OF BUSINESS DEVELOPMENT, Synergy Health (formerly BeamOne), Tampa, FL Developed and executed strategic business development initiatives and sales activities. Evaluated current market trends, competitor activities, and emerging markets. Identified, established, and maintained exceptional relationships with new customers. Worked with existing and potential customers in their understanding of validation protocols, validation execution, product testing, material compatibility issues, and product & package testing. Negotiated and closed company contracts with customers. Provided technical expertise and consulting to external and internal customers on aspects of sterilization validation, routine processing, and associated biological, chemical, and physical testing. MDR SPECIALIST, Medtronic Surgical Technologies, Jacksonville, FL Reported medical device adverse events to FDA Customer compliant handling Training Special projects QUALITY CONSULTANT (Medtronic), Validant, Jacksonville, FL Retrospective review of CAPAs Remediation of CAPAs CAPA Investigations, Corrections, Corrective / Preventive Actions and ensure the CAPA closed appropriately Customer Complaint Handling QUALITY CONSULTANT (Zimmer), Maetrics LLC, Dover, Oh & Warsaw, IN Interim CAPA Coordinator o Retrospective Review of CAPAs o Remediation of CAPAs o Upgraded CAPA process. o CAPA Investigations, Corrections, Corrective / Preventive Actions and ensure the CAPA closed appropriately. o CAPA Committee Meetings Conduct Internal / Supplier Audits. Training Quality Systems Regulations, Good Documentation Practices, Corrective and Preventative Actions, New Hire Orientation. Page 2 of 5

3 FDA Readiness Plan. Oversaw all inspections and calibration activities, release of work orders, and approve change orders. QUALITY CONSULTANT, LexaMed, Ltd., Toledo, OH Supplier Audits Document Control Laboratory Investigation Reviews Non-Conforming Material Reviews Procedure Reviews and Re-Writes FDA Readiness Plans MANAGER OF QUALITY, J and J Scientific Products, Inc., Tampa, Florida Responsible for overall activities including quality assurance, quality control and regulatory affairs. Developed and maintained quality systems that will assure compliance to cgmp standards and regulations for Medical Devices. Defined implementation plan to achieve ISO certification. Worked with customers to resolve customer complaints. Determined root cause analyses of non-conforming material and recommend corrective action. Developed and executed Equipment Qualifications (IQ/OQ/PQ) protocols and process validation protocols. Oversaw all inspections and calibration activities, release of work orders, and approve change orders. Maintained all quality records. Key team player for all customer and supplier external audits. SENIOR QUALITY ENGINEER, Baxter Healthcare Corporation, Largo, Florida Project Manager responsible for the tracking and closure of all outstanding corrective actions generated from supplier and internal audits. Analyzed activities pertaining to Supplier Approval process. Coordinated the alignment of Supplier Quality Approval/Auditing process with corporate procedures. Implemented, deployed and maintained an approved supplier list for both Direct and Service suppliers. Tracking/trending supplier performance. Page 3 of 5

4 Successfully performed supplier audits and internal audits. Tracked and facilitated closure of corrective actions of all supplier and internal audits. Assisted in the training of new personnel within the Supplier/Internal Auditing Group. QUALITY ASSURANCE MANAGER, Mastertaste, Inc., Lakeland, FL Supervision of all QA Inspectors/Technicians. Reviewed ISO 9001/13485 and FDA quality systems (QSR) training for all employees. Developed, reviewed, and analyzed data, records and products to determine if quality standards and specifications are achieved. Reporting of quality functions through verbal and written reports, as well as CAPA. Formulated and maintained quality assurance objectives with production procedures to maximize product reliability and minimize costs. Maintained, assigned and controlled: Part Numbers, Product Codes, BOMs, DHR s, DMR s and Quality Plans. Management of Customer Complaints. QUALITY ASSURANCE MANAGER, ASO Corporation, Sarasota, FL Supervision of QA Inspectors/Technicians including interviewing, training, planning/assigning/directing work, appraisal performances, addressing complaints and resolving problems. Reviewed ISO 9001/13485 and FDA quality systems (QSR) training for all employees. Developed, reviewed, and analyzed data, records and products to determine if quality standards and specifications are achieved. Formulated and maintained quality assurance objectives with production procedures to maximize product reliability and minimize costs. Maintained, assigned and controlled: Part Numbers, Product Codes, BOMs, DHR s, DMR s and Quality Plans. Corrective/preventive action and reporting. Management of Customer Complaints. Management of supplier non-conformance and corrective/preventive action systems. Page 4 of 5

5 Management of the system for disposition, rework, and/or purge of nonconforming materials. Implemented, updated, and modified ISO/QSR procedures and work instructions. Developed and implemented validation protocols and reports for new products and equipment. Assisted VP of QA/RA with special projects. Additional positions held: MICROBIOLOGY LAB SUPERVISOR/RESEARCH ASSOCIATE/QUALTIY CONTROL, NABI, Inc., Rockville, MD ENVIRONMENTAL MICROBIOLOGIST, Westwood Squibb Pharmaceuticals, Buffalo, NY DOCUMENT COORDINATOR/MICROBIOLOGY, Ethox Corporation, Buffalo, NY Education Gannon University, Erie, Pennsylvania. o B.S., Major: Biology, Minor: Medical Technology Professional Seminar and Training Programs HACCP Training Dale Carnegie - Effective Speaking - Graduate Dale Carnegie - Effective Speaking - Graduate Assistant Dale Carnegie - Good Management Makes Great Things Happen Kepner-Tregoe Problem Solving and Decision Making Interpersonal Management Skills Situational Leadership Internal Auditor Training for ISO Organizations Florida Medical Manufactures Consortium (FMMC), Member 2013 current Bio Florida, Member 2013 current Certifications American Society of Quality Quality Auditor, CQA Page 5 of 5