Dave Kuchta
Director of Quality and Regulatory at Safetec of America, Inc. | Buffalo, New York, United States
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Dave Kuchta serves as the Director of Quality and Regulatory at Safetec of America, Inc., where he plays a pivotal role in ensuring that the company adheres to the highest standards of quality and regulatory compliance within the life sciences sector. With a robust background as a trained pharmaceutical microbiologist, Dave brings a wealth of expertise in administering ISO and Quality Management Systems across the Drug, Device, and Chemical Excipient industries. His leadership in overseeing the company’s Quality Systems is instrumental in maintaining compliance with FDA regulations and ensuring that all products meet stringent quality standards.
In his current role, Dave collaborates closely with various departments, including Manufacturing and Engineering, to drive continuous improvement projects that enhance operational efficiency and product quality. His ability to integrate Quality and Regulatory inputs into developmental projects is crucial for aligning Safetec’s strategic objectives with regulatory requirements, ultimately fostering innovation while safeguarding public health.
As a certified ASQ Auditor and a seasoned instructor of Good Manufacturing Practices (GMP) training, Dave is dedicated to workforce development and professional continuing education within the life sciences community. His commitment to quality auditing and cleaning validation further underscores his expertise in ensuring that all processes are compliant and effective. With skills that encompass a broad spectrum of quality assurance and regulatory knowledge, including GAMP and microbiology, Dave Kuchta is a key asset to Safetec of America, Inc., driving excellence in quality and regulatory operations.
Director of Quality and Regulatory at Safetec of America, Inc. in June 2023 to Present
Director, Athenex Inc., CMC Research Operations at Athenex in May 2022 to June 2023
Quality Assurance Manager- Clinical CMC at Athenex in March 2016 to June 2023
Quality Assurance Manager, Manufacturing at QuaDPharma, LLC (Athenex Pharma) in May 2013 to November 2015
QC/QA Lead at VWR, part of Avantor in February 2011 to May 2013
Director of Quality Assurance and Regulatory Affairs at Harmac Medical Products in January 2009 to January 2010
QA Manager at Astellas Pharma Manufacturing Inc. in June 2000 to April 2009
Director of Quality at American Pharmaceutical Partners in April 1983 to June 2000
Quality Control Manager, Chemistry and Microbiology at Fujisawa Healthcare Inc in January 1996 to January 2000
Quality Control Manager, Microbiology and Physical Process Control at Fujisawa Healthcare Inc. in December 1993 to December 1995
Other QC/QA Positions at Fujisawa Healthcare Inc. in April 1983 to November 1995
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Pharmaceutical and Medical Device Quality experience
ASQ Certified as a CSSGB
CQA.CBA
CQIA
Pharmaceutical Microbiologist
Experienced Manager for Life Science companies
Trainer in Biomanufacturing
Internal and External Auditor
Pharmaceutics
Lifesciences
Medical Devices
GMP
Quality System
V&V
Internal & External
Validation
CAPA
Quality Assurance
Six Sigma
Regulatory Affairs
ISO
Quality Control
Microbiology
Continuous Improvement
Sop
GLP
Biotechnology
Pharmaceutical Industry
Change Control
ISO 13485
Aseptic Processing
FDA
Quality Auditing
Regulatory Requirements
Quality Management
Root Cause Analysis
FDA GMP
CQA
Laboratory
21 CFR Part 11
Biopharmaceuticals
Chemistry
LIMS
Computer System Validation
Trackwise
Sterilization
Regulatory Submissions
Cleaning Validation
Technology Transfer
GAMP
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Discover more about Safetec of America, Inc.What is Dave Kuchta email address?
Email Dave Kuchta at [email protected] and [email protected]. This email is the most updated Dave Kuchta email found in 2026.
What is Dave Kuchta phone number?
Dave Kuchta phone number is +17164457244 and +17164272908.
How to contact Dave Kuchta?
To contact Dave Kuchta send an email to [email protected] or [email protected]. If you want to call Dave Kuchta try calling on +17164457244 and +17164272908. (updated on October 30, 2024)
What company does Dave Kuchta work for?
Dave Kuchta works for Safetec of America, Inc.
What is Dave Kuchta's role at Safetec of America, Inc.?
Dave Kuchta is Director of Quality and Regulatory
What industry does Dave Kuchta work in?
Dave Kuchta works in the Hospitals And Health Care industry.
Dave Kuchta Email Addresses
Dave Kuchta Phone Numbers
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