Michael Buehner Email and Phone Number
Michael Buehner work email
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Michael Buehner personal email
Quality Management , Compliance, and R&D Professional with experience in and knowledge of domestic and international Quality Systems, Audit Programs, Standards, Methodologies and Protocols in the Healthcare, Pharmaceutical, R&D and Manufacturing sectors. Resolute problem-solver with excellent communication and interpersonal skills. Strong analytical thinker, well-organized with ability to work independently or in a team environment. Commitment to high standards and goals achievement coupled with strong work ethic will contribute to bottom line results. Key skills include: • Quality Systems / Audits• Staff Supervision / Training • Audit and Trainer to ISO 9001:2015, ISO 13485:2016, 21CFR820, 21CFR211, 21CFR212, CMDR, MDD (MDR), MDSAP, and ANVISA• CAPA Management • Tracking / Trending / Data Analysis• Analytical Methodologies • Computer Modeling• Project Management • Test Oversight• Laboratory Management • Performance Improvement• Product / Process Development • Standards Development
Olympus Corporation
View- Website:
- olympus-global.com
- Employees:
- 13431
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Principle Q And R Global AuditorOlympus CorporationBeachwood, Oh, Us
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Principle Q&R Global AuditorOlympus Corporation Oct 2023 - PresentShinjuku-Ku, Tokyo, Jp
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Quality Manager, UsaAvery Dennison Jan 2021 - Oct 2023Mentor, Ohio, UsQuality Manager, USADevelop and maintain and ISO1345:2016 QMS for Avery Medical USA locations. Responsible for managing all the Quality Programs domestically as well as international. Position includes managing a Quality Staff including: Documentation, Retention Coordinator, and Training Coordinator, 2 Quality Engineers, 3 Quality Technician, and an administrative assistant. Programs manage include: CAPA, Change Control, receiving, in process, and final testing of materials and products, Validation Program, Change Control, Internal Audit, and Complaint handling. -
Senior Global Corporate Compliance AuditorPhilips Jun 2016 - Dec 2021Amsterdam, Noord-Holland, NlSenior Global Corporate Auditor performs risk based compliance audits of Philips Global Medical locations. Audit to 21CFR820, ISO12485:2016, ISO 9001:2015, JPAL, MDR, ANVISA, CMDR, and MDSAP, and in compliance with corporate auditing program procedures and policies on 6 continents. -
Manager, Regulatory AuditCardinal Health Oct 2010 - May 2016Dublin, Oh, UsResponsible for conducting corporate regulatory audits in the pharmaceutical and medical device divisions of Cardinal Health. International position performing audits in the US, Mexico, Canada, Europe, Asia, and the Caribbean. Audit against 21CFR210, 211, 11, 820, and ISO 13485 & 11137. Responsibilities include: maintain audit schedules, manage CAPAs, and provide regulatory training -
Quality Manager - RegionalAmerican Sugar Refining Jul 2008 - Oct 2010West Palm Beach, Fl, Us(2), Nashville, Orlando, and Dallas)• Established Quality System for 6 locations which included Creating Quality Manuals• Developed, maintained, and standardized the following programs: Document Control, Training, CAPA, Internal Audits, complaint handling, • Support all plants for third party and customer audits• Conduct Compliance audits biannually to all Non-refinery locations and manage corrective actions -
Corporate Quality Systems Compliance LeaderSteris Corporation Jul 2008 - Apr 2009Mentor, Oh, UsResponsible for the management of the International Corporate Quality Systems Audit Program.• Performed all audits for domestic and international company manufacturing facilities and suppliers to assure compliance with ISO 9000, 21CRF part 820, MDR, CMDR and GLP standards.• Developed and managed all corrective action programs from audit findings compliance to regulatory and corporate requirements• Developed and implemented new standards such as Document Control, Risk Management, Training, Root Cause Analysis and CAPA.• Conducted and managed company- wide audit programs as a solo practitioner, replacing 3 Auditor predecessors.• Provided ISO / GMP training worldwide utilizing training methodologies, videos, literature, quizzes to ensure plant and employee compliance with annual training requirements. -
Scientist, Drug Development And ManufactureCogensys Oct 2003 - Jul 2007Established and managed the Quality Control program for the startup organization. Responsible for overseeing Scheduling, analysis and release of in-process, bulk FDP, and Stability of phase1, 2, 3 drug material. Oversaw residual testing which included residual DNA, residual vegan Protein a, and residual Host Cell Protein. Supervised ~ 14 Drug development and Manufacture Analysts. • Reviewed all Analytical Test Records in order to release drug material.• Tracked and trended all analytical data to better understand the nature of the molecules.• Established specifications for drug materials to ensure product integrity, manufacture guidelines for their processes as well as FDA requirements for bulk and final drug product.• Established and managed Stability program, per ICH Guidelines, which included > 10 studies.• Functioned as Department Project Manager to track project status and progress and performed gap analysis studies.
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Manager, Quality Control And AssuranceMeso Scale Discovery Apr 2001 - Oct 2003Rockville, Maryland, UsHired as a Scientist to develop Quality Control laboratory protocols. Subsequently developed a complete Quality Control and Assurance Program. Supervised 3 FTE’s.• Developed quality control test methods including Immunoassays, HPLC, Microbiological and OGP.• Established all Quality Control Standard Operating Procedures ( SOP’s)• Established a Stability Program to establish expiration dates and storage requirements.• Conducted both internal and external audits against ISO 9000, 13485, 21CFR part 820 and 11 standards.• Active role in liaison between R&D and Manufacturing. Member of Tech Transfer, Product Development and Process Development teams.
Michael Buehner Education Details
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Pennwest EdinboroIndustrial Biochemistry/Chemistry -
Lake Catholic High SchoolCollege/University Preparatory And Advanced High School/Secondary Diploma Program
Frequently Asked Questions about Michael Buehner
What company does Michael Buehner work for?
Michael Buehner works for Olympus Corporation
What is Michael Buehner's role at the current company?
Michael Buehner's current role is Principle Q and R Global Auditor.
What is Michael Buehner's email address?
Michael Buehner's email address is mi****@****son.com
What schools did Michael Buehner attend?
Michael Buehner attended Pennwest Edinboro, Lake Catholic High School.
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