Mark Balboni
Principal & General Manager @Balboni Consulting Group Llc
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WORK HISTORY
Principal & General Manager @Balboni Consulting Group Llc
Bend, OR, US
Owner and Founder of a GMP and Quality Systems consulting firm, providing timely services to clients in the pharmaceutical, biotechnology, and medical device industries, both in the US and internationally.Portfolio of GMP Consulting Services:• GMP AUDITING: Sterile and non-sterile finished products/devices, suppliers of APIs and raw materi-als, testing labs, warehouses (GDP). This includes large and small molecule products as well as celland gene therapy treatments.• STRATEGIC ADVISEMENT: Healthcare authority communications/meetings, remediation and verifica-tion• INSPECTION SUPPORT: Hosting, front/back room support, mock interviews, etiquette training, readi-ness assessments, application conformance reviews• DATA INTEGRITY: Training, procedure development, auditing, staff interviews, internal investigations,coordination with legal counsel• DEVIATION INVESTIGATIONS & CAPA: Problem identification and resolution, report writing• TRAINING: General GMP topics, FDA interaction and preparation for FDA inspections, 1:1 mock in-terviews, auditing techniques• TECHNICAL WRITING: Validation protocols and reports, SOPs, annual product reviews, FDA corre-spondence, audit responses, strategic plans, trend analysis reports, and other technical reports• DATA / TREND ANALYSIS: Collection, review, analysis, and summary reporting for deviations, OOS,change controls, CAPA, complaints, product returns• PROJECT MANAGEMENT: Compliance remediation efforts, organizational/systems redesigns
EDUCATION
Weber State University
Bachelor of Science (B.Sc.), Zoology, Chemistry
SKILLS
ABOUT MARK BALBONI
I am an experienced Quality Assurance and Good Manufacturing Practice generalist with a breadth of skills and adaptability, who is also a problem solver and data analyzer. I also enjoy being a mentor and a coach, which is especially rewarding as you witness the learning and growth over time.KEY SKILLS• Extensive knowledge concerning the cGMP regulations and compliance requirements,especially the applicability in an R&D environment, as well with novel technologiessuch as cell & gene therapy and complex issues like data integrity matters.• School-trained in quality assurance principles, statical process control, inspectiontechniques, conducting interviews• Highly skilled in problem detection and identification, developing solutions in short andlong-term corrective actions; as well as elimination of unnecessary work and seekingefficiencies in processes.• Quite comfortable working in a variety of settings, including startups and R&D-orient-ed ventures, medium-sized firms on up to multinational pharmaceutical and biotech-nology companies• Knowing what good looks like and what it takes to be best-in-class
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