Kym Faylor, Email and Phone Number
Kym Faylor, work email
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Kym Faylor, personal email
Kym Faylor, phone numbers
Professional with twenty three years of experience in assuring international compliance with governing agencies, client specifications, developing and leading the quality assurance aspect to conform to current advances in pharmaceutical, medical device, biotechnology and cosmetic industries. I have implemented techniques obtained from my ASQ certifications as a Quality Auditor (CQA) and Manager of Quality/Organizational Excellence (CMQ/OE) in developing company wide quality systems, including the master validation plan and quality assurance manuals. I have an extensive background in microbiology, specializing in validation of microbiological methods and compendial testing. My experience includes compliance with USP, FDA, ISO, EU, AAMI & AOAC requirements, general microbiology testing, and microbiology quality system programsSpecialties: Regulatory ComplianceQuality System DevelopmentMicrobiological Validation TestingMethod DevelopmentEnvironmental Monitoring
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President - Gillson Testing A Division Of Gillson SciencesGillson SciencesAllentown, Pa, Us -
President Azzur Labs Testing Services, PartnerAzzur Group Sep 2024 - PresentHatboro, Pennsylvania, Us -
Executive Vp, Innovation & GrowthAzzur Group Jan 2024 - Aug 2024Hatboro, Pennsylvania, Us
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Coo Azzur Labs Testing ServicesAzzur Group Mar 2012 - Jan 2024Hatboro, Pennsylvania, UsTasked with the opening of multiple laboratories across the US with services including microbiology, chemistry, molecular and cell therapy testing services.Develops the business strategy for the upcoming year & tracks performance.Sets strategic direction for all labs including short and long term goals.Develops the business by establishing and maintaining positive relationships with new and existing clients.Supports the attraction, hiring, development, and retention of skilled resources for the delivery of services.Develops, drives, and manages the revenue and profitability on an annual basis.Manages service execution by providing subject matter expertise, overseeing each Sr. Director’s productivity and quality, and providing hands-on support, if needed.Leveraging and expanding industry knowledge and contacts to grow the businessProvide input and support marketing initiatives as neededTranslate new and existing client needs into actionable value-added projects/resultsPrepare and deliver capability presentations, proposals, and agreements for new and existing clientsDevelop, monitor and maintain key performance indicators
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Laboratory DirectorMicrobiological Environments Aug 1997 - Mar 2012Assure compliance with client specifications, FDA, CTFA, USP, EU, JP, ISO standards as required.Distinguished the differences between international regulatory requirements and develops methods which comply with multiple organizations.Reviewed and approved all laboratory qualification protocols.Drafted development and validation protocols, optimizes existing research methods and oversaw transfers of previously validated methods.Managed all laboratory projects.Researched & evaluates current technologies for implementation into laboratory operations.Represented the company at all regulatory and client audits.Supervised & managed laboratory personnel to include payroll, promotions, performance evaluations, conflict resolution etc.Managed all business expenses, equipment purchases, benefits administration, payroll & accounts receivable.Developed the business strategy for upcoming year & tracks performance.Development and management of the marketing plans and strategies. Designs website and marketing materials for publication.Key Achievements:Developed specialized testing for release of clinical trial products to meet FDA, ISO and EU regulatory requirements.Drafted, developed and instilled all laboratory quality systems, including the Master Validation Plan, Safety Manual and the Conflict of Interest Policy
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Quality Assurance, ManagerMicrobiological Environments Jan 2003 - Jan 2006Developed, presented & evaluated training and continuing education programs. Developed teams & delegated project tasks based on technical aptitude & experience.Represented the company at all regulatory and client audits. Tracked laboratory observations and deviations and developed corrective and preventative actions. Monitored customer complaints and develop resolutions.Key Achievements:Drafted, developed and instilled laboratory quality systems, including the Quality Assurance Manual, Quality Systems Evaluation and the Employee Manual.
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MicrobiologistMicrobiological Environments Aug 1997 - Jan 2003Responsible for all training in SOP’s, Protocols and continuing education for laboratory personnel. Develop data management and trend analysis programs.Bioburden testing and determination of appropriate irradiation levels for client specified SAL.Write Standard Operating Procedures and Protocols for all equipment and practices within the lab environment.Observe / comply with CGXP and procedures.Responsible for conducting all microbiological testing, including - Microbial limit testing, antimicrobial effectiveness testing (USP; CTFA), log reduction of bacterial spores, culture maintenance, water testing, environmental monitoring analysis, bacterial endotoxin detectionMicroscopy - Mold identification; bacterial identification (API, BBL Crystal systems), Identification of starch particles through polarized light microscope, microphotography.Bacteriophage genetic manipulationCleanroom environmental monitoring (RCS, RCS Plus, SAS, MAS 100, Climet, Metone).
Kym Faylor, Skills
Kym Faylor, Education Details
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Wharton Executive EducationM&A And Corporate Development Strategies -
Cornell UniversityLeadership And Strategic Management
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Penn State UniversityFood Microbiology
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Massachusetts Institute Of TechnologyDepartment Of Aeronautics And Astronautics
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Uc San DiegoRegulatory Affairs
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Cedar Crest CollegeGeneral Science
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William Allen High School
Frequently Asked Questions about Kym Faylor,
What company does Kym Faylor, work for?
Kym Faylor, works for Gillson Sciences
What is Kym Faylor,'s role at the current company?
Kym Faylor,'s current role is President - Gillson Testing a Division of Gillson Sciences.
What is Kym Faylor,'s email address?
Kym Faylor,'s email address is ky****@****abs.com
What is Kym Faylor,'s direct phone number?
Kym Faylor,'s direct phone number is 800-726*****
What schools did Kym Faylor, attend?
Kym Faylor, attended Wharton Executive Education, Cornell University, Penn State University, Massachusetts Institute Of Technology, Uc San Diego, Cedar Crest College, William Allen High School.
What skills is Kym Faylor, known for?
Kym Faylor, has skills like Fda, Validation, Quality System, Gmp, Biotechnology, Capa, Quality Assurance, Microbiology, Sop, Pharmaceutical Industry, Glp, Environmental Monitoring.
Who are Kym Faylor,'s colleagues?
Kym Faylor,'s colleagues are Patrice Papa, David N. Precht, Glen Hronich, Parth Sarkango, Joshua Lawrence Nabatilan, Julie Lynn, Ashish Thapa, Ms.
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