Michael Buehner Email & Phone Number

Beachwood, Oh, Us

Shinjuku-Ku, Tokyo, Jp

Mentor, Ohio, Us

Quality 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.

Amsterdam, Noord-Holland, Nl

Senior 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.

Dublin, Oh, Us

Responsible 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

West 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

Mentor, Oh, Us

Responsible 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.

Established 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.

Rockville, Maryland, Us

Hired 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.

Bachelor Of Science (Bs), Industrial Biochemistry/Chemistry

High School, College/University Preparatory And Advanced High School/Secondary Diploma Program