Title: Senior Quality Assurance Consultant
Company: The FDA Group
Location: San Juan, Puerto Rico
Melvin Colón, MEM, MSMC, senior quality assurance (QA) consultant at The FDA Group, has been recognized by Marquis Who’s Who Top Executives for dedication, achievements, and leadership in quality assurance and pharmaceuticals.
Developing his skills across a career spanning more than 25 years, Mr. Colón has served as a senior QA consultant at The FDA Group since 2024. Through this venture, he aids clients who are looking to take new products to market by helping ensure that they meet various regulatory requirements. Most recently, Mr. Colón has been working with a vaccine manufacturer based in Mexico, where he identified notable gaps in their processes and was able to propose an alternative approach that would lead to a greater likelihood of regulatory success. He has previously been hired by clients in Korea, India, the United States and beyond, demonstrating a truly global level of expertise in his field.
Prior to his time with The FDA Group, Mr. Colón has honed his skills as a senior QA consultant at The Henrici Group, LST Consulting USA, NATCO Pharma, 5Ws GxPertise, the Gintegra Group, Quality Executive Partners Inc. and Operations & Quality Systems Improvement Experts. He previously contributed as a QA consultant at Anobri Pharmaceuticals US LLC; QA lead at the Luttrell Group, JI Solutions and GK Regulatory Compliance; senior compliance engineer at MCD Consulting Services; head of quality assurance at Buoyant Pharma; validation consultant at Genentech Inc., GlaxoSmithKline, Bristol-Myers Squibb Company, RCM Technologies Inc., Cardinal Health and Pharmacia Corporation; and project manager at Cordis. Mr. Colón has provided insight at sites focused on general pharmaceuticals, compounding, dietary supplements, combination products, remediation, biotech, medical devices. His career began with a job in raw material lab chemistry at McNeil Consumer Products Inc. in 1997, followed by a position as a laboratory technician in the Searle Company Ltd.
Mr. Colón’s career trajectory has been supported by a strong education, beginning with a Bachelor of Science in industrial chemistry from the University of Puerto Rico in 1997. He obtained a master’s degree in engineering management from the Polytechnic University of Puerto Rico in 2000. Returning to that institution in 2010, Mr. Colón earned a Master of Science in manufacturing competitiveness. He has bolstered his credentials with a number of certifications from Qualistery, including in e-signatures in pharma and how to audit suppliers and contractors.
Noted for his achievements in the field, Mr. Colón has been the subject of a variety of accolades. He has received awards recognizing his performance throughout his professional life, including two cash awards based on his execution of ambitious goals. Mr. Colón considers the highlight of his career to be his work on consent decrees in the pharmaceutical space. In his first role as a consultant, he was able to present a work stream that was accepted without any issues from the Small Business Administration, earning him immediate recognition and performance bonuses. Mr. Colón credits his success to perseverance and dedication to his goals, even when they’re difficult. He recalls one scenario in which a study done by a third-party company failed to meet his quality standards, and he took responsibility and worked for 27 hours straight to ensure a positive outcome.
In addition to his professional life, Mr. Colón is a devoted husband and a loving pet owner to 13 dogs. He finds great joy in traveling, both within work and in his free time, and in learning about different cultures. Looking to what’s next, Mr. Colón hopes to make an increasingly meaningful impact in the pharmaceutical space in the years ahead, with a focus on making sure companies are as prepared as possible for inspections. He views his work as an essential step in the process toward getting innovative medical products to patients who will benefit from them.
For more information, please visit:
Contact Mr. Colón:
