Duane Whitaker
Compliance Specialist and Project Management at Regeneron Pharmaceuticals, Inc. | Smithfield, North Carolina, United States
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Duane Whitaker is a seasoned Compliance Consultant at Regeneron Pharmaceuticals, Inc., where he leverages over 26 years of extensive experience in the biotechnical and pharmaceutical industries. His role is pivotal in ensuring that Regeneron adheres to stringent FDA regulatory requirements, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other critical compliance standards such as ISO and ICH guidelines. Duane's expertise in Quality Compliance and deviation management allows him to navigate complex regulatory landscapes effectively, ensuring that projects not only meet compliance benchmarks but also align with the company's strategic objectives.
Currently, Duane is spearheading several key projects that focus on enhancing procedural documentation and engineering documentation processes. His adeptness in project management enables him to oversee the implementation of robust change control systems and validation protocols, which are essential for maintaining the integrity of Regeneron's innovative biopharmaceutical products. Additionally, Duane plays a crucial role in exception management and corrective action/preventive action (CAPA) initiatives, where his analytical skills and problem-solving capabilities shine.
With a strong foundation in technical writing, Duane excels at crafting comprehensive Standard Operating Procedures (SOPs) that not only comply with regulatory standards but also promote operational efficiency. His excellent planning, organizational, and time management skills ensure that projects are delivered on time and within scope, making him an invaluable asset to Regeneron’s compliance team. As the biopharmaceutical landscape continues to evolve, Duane Whitaker remains at the forefront, driving quality and compliance initiatives that support Regeneron’s mission of delivering groundbreaking therapies to patients.
Compliance Specialist and Project Management at Regeneron Pharmaceuticals, Inc. in September 2016 to Present
Compliance Consultant/Validation Support/Technical Writer/Project Support/Change Control at Novo Nordisk in January 2014 to September 2016
Quality Project Support/Change Control/ Validation/Document Revisions-Independent Consultant at Novo Nordisk in May 2013 to January 2014
Compliance Consultant - Deviation/Nonconformances/Exception Investigations - Independent Consultant at Mallinckrodt Pharmaceuticals in August 2012 to January 2013
Nonconformances / Exceptions Reduction Project - Independent Consultant at Mallinckrodt Pharmaceuticals in May 2012 to August 2012
QA Project Manager/Nonconformances/CAPAs - Consultant representing National-Pharma & Biotech Solns at Mallinckrodt Pharmaceuticals in February 2012 to May 2012
Documentation Specialist - Independent Consultant representing Amris Consulting at Novo Nordisk in January 2012 to February 2012
Investigative Writer / CAPA at Grifols in January 1996 to December 2011
Documentation Author/Specialist at Grifols in January 1996 to December 2011
Manufacturing Associate / OJT Trainer at Grifols in January 1996 to November 2011
Lead Quality Inspector - Quality Assurance at Johnson and Johnson in April 1992 to January 1996
Chemist/Laboratory Technician at Webb Technical Group in June 1987 to April 1992
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NC State University, January 1986 to January 1992
Johnston Community College
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Project Management
Technical Documentation
Document Preparation
Engineering Documentation
Procedural Documentation
Exception Management
Incident Management
Corrective Actions
Process Improvement
FDA GMP
Pharmaceutical Industry
Pharmaceutical Consulting
Biotechnology Industry
Independent Contractors
Exceptions
Quality Assurance
Root Cause Analysis
Change Control
Technical Writing
Validation
LIMS
Trackwise
Aseptic Processing
FDA
SOP
CAPA
21 CFR Part 11
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What is Duane Whitaker email address?
Email Duane Whitaker at [email protected], [email protected] and [email protected]. This email is the most updated Duane Whitaker's email found in 2025.
What is Duane Whitaker phone number?
Duane Whitaker phone number is 9194646972 and 9199389834.
How to contact Duane Whitaker?
To contact Duane Whitaker send an email at [email protected], [email protected] or [email protected] you want to call Duane Whitaker try calling on 9194646972 and 9199389834.
What company does Duane Whitaker work for?
Duane Whitaker works for Regeneron Pharmaceuticals, Inc.
What is Duane Whitaker's role at Regeneron Pharmaceuticals, Inc.?
Duane Whitaker is Compliance Specialist and Project Management
What industry does Duane Whitaker work in?
Duane Whitaker works in the Pharmaceuticals industry.
Duane Whitaker Email Addresses
Duane Whitaker Phone Numbers
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