Leadership Committee
Emile Najm (845) 639-3622
Section Chair, Membership Chair - NEQC Representative
Emile Najm is a Mechanical Engineer, an ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) and Certified Six Sigma Black Belt (CSSBB). Emile currently is a Sr Product Engineer at Aptargroup, a solution provider for innovative and proven spray, aerosol, and lotion dispensing system. Emile has been a member of ASQ since 2005, and joined the ASQTZ board in 2009.
Section Chair, Membership Chair - NEQC Representative
Emile Najm is a Mechanical Engineer, an ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) and Certified Six Sigma Black Belt (CSSBB). Emile currently is a Sr Product Engineer at Aptargroup, a solution provider for innovative and proven spray, aerosol, and lotion dispensing system. Emile has been a member of ASQ since 2005, and joined the ASQTZ board in 2009.
Steven Walfish
Secretary
Steven Walfish, MS, MBA is a Staff Statistician at Becton Dickinson (BD) in Franklin Lakes, NJ. Mr. Walfish is responsible for non-clinical statistical support for operations, quality and product development. Prior to joining BD in 2012, Mr. Walfish was a Statistician at GE Healthcare in Waukesha, WI responsible for global statistical support. Prior to joining GE Healthcare, Mr. Walfish had a statistical consulting company that provides statistical analysis and training to the FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.
Mr. Walfish brings over 25 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.
Mr. Walfish has been an invited lecturer at Medical Design and Manufacturer (MD&M), Institute of Validation Technology (IVT) and Advanstar conferences. Mr. Walfish has been a speaker at ASQ Division and Section conferences. He is also an editorial board member for BioPharm International, and a regular contributor to the magazine.
Mr. Walfish is the secretary for TAG69, senior member of ASQ, a certified quality engineer and past chair of the Biomedical Division (2006-07). Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.
Secretary
Steven Walfish, MS, MBA is a Staff Statistician at Becton Dickinson (BD) in Franklin Lakes, NJ. Mr. Walfish is responsible for non-clinical statistical support for operations, quality and product development. Prior to joining BD in 2012, Mr. Walfish was a Statistician at GE Healthcare in Waukesha, WI responsible for global statistical support. Prior to joining GE Healthcare, Mr. Walfish had a statistical consulting company that provides statistical analysis and training to the FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.
Mr. Walfish brings over 25 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.
Mr. Walfish has been an invited lecturer at Medical Design and Manufacturer (MD&M), Institute of Validation Technology (IVT) and Advanstar conferences. Mr. Walfish has been a speaker at ASQ Division and Section conferences. He is also an editorial board member for BioPharm International, and a regular contributor to the magazine.
Mr. Walfish is the secretary for TAG69, senior member of ASQ, a certified quality engineer and past chair of the Biomedical Division (2006-07). Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.
Jan Michael Gonzales (845) 602-1703
Treasurer
Jan Michael Gonzales is s
Treasurer
Jan Michael Gonzales is s
Katherine Tsetsekos
Audit Chair
Katherine Tsetsekos is an Audit Manager at Pfizer Inc. in Pearl River, NY. Ms. Tsetsekos has 15 years experience in the pharmaceutical industry. She is an ASQ Certified Quality Auditor (CQA) and currently works as an internal pharmaceutical and supplier auditor. Her experience includes stability testing and management, aseptic processing, compliance, quality assurance and auditing. Katherine holds a BS in Biology from Cornell University. She has been a member of ASQ Tappan Zee since 2004.
Audit Chair
Katherine Tsetsekos is an Audit Manager at Pfizer Inc. in Pearl River, NY. Ms. Tsetsekos has 15 years experience in the pharmaceutical industry. She is an ASQ Certified Quality Auditor (CQA) and currently works as an internal pharmaceutical and supplier auditor. Her experience includes stability testing and management, aseptic processing, compliance, quality assurance and auditing. Katherine holds a BS in Biology from Cornell University. She has been a member of ASQ Tappan Zee since 2004.
Nalukui Mwisiya
Programs Chair
Nalukui Mwisiya is currently Senior QA auditor at PAR Pharmaceutical, Spring Valley, NY. She is an Organic Chemist with strong GMP an Scientific Sourcing Background. She has over 30 years experience in the Pharmaceutical Industry of which 23 were in Chemical Development as a Chemist and Scientific Sourcing Lead with Wyeth (now Pfizer) in Rouses Point, NY and Pearl River, NY.
She holds a Bachelor of Science degree in Chemistry (Oral Roberts University, Tulsa, OK), Master of Science in Pharmacy major Medicinal Chemistry from the University of Arizona, Tucson, Arizona and an MBA, Finance from Long Island University, Orangeburg, NY.
She has been a member of ASQ since 2012 and is a Certified Quality Auditor.
Programs Chair
Nalukui Mwisiya is currently Senior QA auditor at PAR Pharmaceutical, Spring Valley, NY. She is an Organic Chemist with strong GMP an Scientific Sourcing Background. She has over 30 years experience in the Pharmaceutical Industry of which 23 were in Chemical Development as a Chemist and Scientific Sourcing Lead with Wyeth (now Pfizer) in Rouses Point, NY and Pearl River, NY.
She holds a Bachelor of Science degree in Chemistry (Oral Roberts University, Tulsa, OK), Master of Science in Pharmacy major Medicinal Chemistry from the University of Arizona, Tucson, Arizona and an MBA, Finance from Long Island University, Orangeburg, NY.
She has been a member of ASQ since 2012 and is a Certified Quality Auditor.
Brian Gilmartin
Voice of the Customer
Voice of the Customer
Linda Sroka (732) 652-5748
Certification Chair - Examining Chair
Linda Sroka is a Senior Manager of Quality Assurance, Americas at Celgene Corp., in Basking Ridge, NJ. She has over 30 years experience in pharmaceutical and veterinary manufacturing as well as global compliance and quality management. Linda has a Bachelor of Science degree in Biology from West Virginia Wesleyan College and currently holds ASQ certifications as a Certified Pharmaceutical GMP Professional; Certified Manager of Quality and Organizational Excellence and Certified Quality Auditor and certification from the New Jersey Pharmaceutical Quality Control Association. Linda joined ASQ in 1988 and has served in the Tappan Zee Section as Chair, Secretary, Audit Chair, and chaired various committees including, Arrangements, Certification, Membership, Nominations, Placement, Publicity, Recertification, and Scholarship. She currently serves the Tappan Zee Section as Certification Chair for exams. Linda also is active with the ASQ Food, Drug & Cosmetic Division. She currently is a member of the CPGP exam committee and will serve as a Co-Chair of the committee for the 2010/2011 term.
Certification Chair - Examining Chair
Linda Sroka is a Senior Manager of Quality Assurance, Americas at Celgene Corp., in Basking Ridge, NJ. She has over 30 years experience in pharmaceutical and veterinary manufacturing as well as global compliance and quality management. Linda has a Bachelor of Science degree in Biology from West Virginia Wesleyan College and currently holds ASQ certifications as a Certified Pharmaceutical GMP Professional; Certified Manager of Quality and Organizational Excellence and Certified Quality Auditor and certification from the New Jersey Pharmaceutical Quality Control Association. Linda joined ASQ in 1988 and has served in the Tappan Zee Section as Chair, Secretary, Audit Chair, and chaired various committees including, Arrangements, Certification, Membership, Nominations, Placement, Publicity, Recertification, and Scholarship. She currently serves the Tappan Zee Section as Certification Chair for exams. Linda also is active with the ASQ Food, Drug & Cosmetic Division. She currently is a member of the CPGP exam committee and will serve as a Co-Chair of the committee for the 2010/2011 term.
John Lyall (854) 742-2066
Recertification Chair
John is currently the President of his own consulting business, Lyall and Associates LLC, specializing in GMP audits and Quality System Review. Previous to starting his consulting business, John held varying positions of increased responsibility in Corporate Quality for several global pharmaceutical companies. He has experience auditing in over 27 countries against multiple regulations and guidance documents. In 1995 he published the book “GMP Auditing by Mail” (© Interpharm Press) and is currently working on an improved version. John joined ASQ in 1988, is ASQ certified with a CQA and CPGP, and is certified by the Registrar Accreditation Board as a Quality Systems Lead Auditor. He joined the ASQTZ Leadership Committee in 2010. John currently resides in Orange County, NY.
Recertification Chair
John is currently the President of his own consulting business, Lyall and Associates LLC, specializing in GMP audits and Quality System Review. Previous to starting his consulting business, John held varying positions of increased responsibility in Corporate Quality for several global pharmaceutical companies. He has experience auditing in over 27 countries against multiple regulations and guidance documents. In 1995 he published the book “GMP Auditing by Mail” (© Interpharm Press) and is currently working on an improved version. John joined ASQ in 1988, is ASQ certified with a CQA and CPGP, and is certified by the Registrar Accreditation Board as a Quality Systems Lead Auditor. He joined the ASQTZ Leadership Committee in 2010. John currently resides in Orange County, NY.
Greg Szczesny (845) 662-1075
Scholarship Chair
Greg L. Szczesny is a New York City-based managing director in PwC's (PricewaterhouseCoopers) Risk Assurance practice. Greg is a senior management advisor with 20 years of experience in supply chain operations and regulatory compliance focused in the diversified industrials, aerospace and defense, automotive and pharmaceutical /medical device sectors. He has significant cross-industry and international experience having worked in the US, Europe and Asia. Greg earned his undergraduate degree in systems engineering from the United States Military Academy (West Point) and completed his MBA from Auburn University. He has been a member of the ASQ Tappan Zee Section since 2009 and is an ASQ Certified Six Sigma Black Belt.
Scholarship Chair
Greg L. Szczesny is a New York City-based managing director in PwC's (PricewaterhouseCoopers) Risk Assurance practice. Greg is a senior management advisor with 20 years of experience in supply chain operations and regulatory compliance focused in the diversified industrials, aerospace and defense, automotive and pharmaceutical /medical device sectors. He has significant cross-industry and international experience having worked in the US, Europe and Asia. Greg earned his undergraduate degree in systems engineering from the United States Military Academy (West Point) and completed his MBA from Auburn University. He has been a member of the ASQ Tappan Zee Section since 2009 and is an ASQ Certified Six Sigma Black Belt.
Stephen Joseph
Webmaster (Internet Liaison)
Stephen Joseph is currently working as a Scientist with Pfizer, Pearl River. He has been with pharmaceutical business for over 10 years. Stephen has also worked in IT industry previously with certifications in Java, MCSA and CCNA. He has been a member of ASQ Tappan Zee since 2012 and is a CQA. Stephen earned his undergraduate degree in Pharmaceutical Sciences from Holkar Science College, India and completed his Masters in Applied Chemistry from Institute of Chemical Sciences, India. He also has Masters in Industrial Pharmacy from LIU, Brooklyn.
Webmaster (Internet Liaison)
Stephen Joseph is currently working as a Scientist with Pfizer, Pearl River. He has been with pharmaceutical business for over 10 years. Stephen has also worked in IT industry previously with certifications in Java, MCSA and CCNA. He has been a member of ASQ Tappan Zee since 2012 and is a CQA. Stephen earned his undergraduate degree in Pharmaceutical Sciences from Holkar Science College, India and completed his Masters in Applied Chemistry from Institute of Chemical Sciences, India. He also has Masters in Industrial Pharmacy from LIU, Brooklyn.
Scott Collins
Immediate Past Chair - Seminar Chair (Acting) - Arrangements Chair (Acting) - Publicity Chair (Acting) - Communications Chair (Newsletter Editor)
Scott has over 25 years of experience in the life science industry. He spent seven years in quality and validation at a pharmaceutical manufacturer before becoming a consultant with QPharma. At QPharma, Scott is both a functional and project manager with full-time employees reporting directly to him, along with teams of personnel reporting to him for specific projects. Scott specializes in equipment qualification and validation for production, packaging, laboratory, and facility/utility systems. His specialties are FDA regulatory compliance, Good Engineering Practices, Equipment Qualification, Validation, and Project Management. Scott also teaches a graduate-level class in regulatory compliance and validation at the NJ Institute of Technology, and is an active member of the ISPE-NJ and ASQ. Scott holds a BA with majors in chemistry and mathematics from the State University of New York at Potsdam, and received his PMP certification in 2011.
Immediate Past Chair - Seminar Chair (Acting) - Arrangements Chair (Acting) - Publicity Chair (Acting) - Communications Chair (Newsletter Editor)
Scott has over 25 years of experience in the life science industry. He spent seven years in quality and validation at a pharmaceutical manufacturer before becoming a consultant with QPharma. At QPharma, Scott is both a functional and project manager with full-time employees reporting directly to him, along with teams of personnel reporting to him for specific projects. Scott specializes in equipment qualification and validation for production, packaging, laboratory, and facility/utility systems. His specialties are FDA regulatory compliance, Good Engineering Practices, Equipment Qualification, Validation, and Project Management. Scott also teaches a graduate-level class in regulatory compliance and validation at the NJ Institute of Technology, and is an active member of the ISPE-NJ and ASQ. Scott holds a BA with majors in chemistry and mathematics from the State University of New York at Potsdam, and received his PMP certification in 2011.
David Levy (914) 772-8512
Region 3 Regional Director
David B. Levy has been involved in the quality profession for over 30 years as a director, manager, engineer, auditor, independent consultant in a variety of industries including telecommunications, defense electronics, commercial electronics, distribution, food manufacturing, ceramics and reinforced plastics.
David is currently the Manager of Quality and Safety at Boyce Technologies, Inc. as well as a Quality Consultant and principal of Levy Quality Consulting, LLC, where he services a variety of clients in all aspects of Quality Assurance, including Quality Management, Quality System Implementation, and Quality Auditing.
David has an MS degree in Operations Management from Polytechnic University and a BS degree in Ceramic Engineering from Alfred University. David is an ASQ Fellow, and also holds four ASQ Certifications (CQMgr, CQE, CQA & CQIA) and is an Exemplar Provisional Auditor.
David served as Region 3 Regional Director from 2003 to 2009 and again from 2012 through present. David has been a member of ASQ since 1990, and joined the ASQTZ Section Leadership Committee in 1994 serving in many positions including: Chair, Vice Chair, Treasurer, Newsletter Editor, NEQC Rep, and Webmaster. He has also served as an ASQ CQA Preparation Trainer. David and his family live in Cortlandt Manor, NY.
David enjoys skiing, swimming, traveling with the family, bicycling, reading, playing poker and spending quality time with his family.
Region 3 Regional Director
David B. Levy has been involved in the quality profession for over 30 years as a director, manager, engineer, auditor, independent consultant in a variety of industries including telecommunications, defense electronics, commercial electronics, distribution, food manufacturing, ceramics and reinforced plastics.
David is currently the Manager of Quality and Safety at Boyce Technologies, Inc. as well as a Quality Consultant and principal of Levy Quality Consulting, LLC, where he services a variety of clients in all aspects of Quality Assurance, including Quality Management, Quality System Implementation, and Quality Auditing.
David has an MS degree in Operations Management from Polytechnic University and a BS degree in Ceramic Engineering from Alfred University. David is an ASQ Fellow, and also holds four ASQ Certifications (CQMgr, CQE, CQA & CQIA) and is an Exemplar Provisional Auditor.
David served as Region 3 Regional Director from 2003 to 2009 and again from 2012 through present. David has been a member of ASQ since 1990, and joined the ASQTZ Section Leadership Committee in 1994 serving in many positions including: Chair, Vice Chair, Treasurer, Newsletter Editor, NEQC Rep, and Webmaster. He has also served as an ASQ CQA Preparation Trainer. David and his family live in Cortlandt Manor, NY.
David enjoys skiing, swimming, traveling with the family, bicycling, reading, playing poker and spending quality time with his family.
Open Positions:
Chair Elect
Arrangements Chair
Publicity Chair
Seminar Chair
Chair Elect
Arrangements Chair
Publicity Chair
Seminar Chair
