Huy Nguyen
Dallas,TX
Summary
Quality assurance professional with extensive experience at Cardinal Health, specializing in cGMP compliance and CAPA implementation. Demonstrated ability to drive organizational growth and improve product quality through effective problem-solving and leadership. Skilled in mentoring teams and managing complex projects, ensuring audit readiness and continuous improvement in quality metrics.
Overview
20
20
years of professional experience
Work History
Principal Specialist, Quality Assurance- PET
Cardinal Health
06.2023 - Current
- Led PET site Quality Assurance operations, including batch record review and release, material disposition, investigation oversight, documentation control, training, and technology transfers in alignment with Cardinal Health Quality Management System.
- Monitored, analyzed, and reported key Quality metrics, driving continuous improvement initiatives aligned with regional and business objectives.
- Directed equipment and facility qualification/validation programs (IOPQ, method validation/verification, calibration, maintenance) to ensure regulatory compliance and operational readiness.
- Partnered cross-functionally with Operations to lead investigations, root cause analysis, and CAPA implementation, improving product quality and reducing deviations.
- Served as a primary Quality representative during internal and external audits, including successful preparation and hosting of FDA inspections, maintaining full audit readiness.
- Acted as Quality Lead for sponsor products, ensuring compliance across lifecycle activities including technology transfer, manufacturing, and release.
- Mentored and developed junior QA staff, strengthening team capabilities and fostering a culture of quality and accountability across multiple sites.
- Reviewed and approved policies, SOPs, and procedures, ensuring alignment with regulatory requirements and standardization across regional operations.
- Managed and contributed to complex, multi-site projects, including technology transfers, new product onboarding, and portfolio expansion initiatives.
- Supported and led material management investigations, including Supplier Corrective Action Requests (SCARs), enhancing supplier quality and compliance.
- Contributed to supplier qualification and oversight programs under Nuclear Precision Health Solutions, ensuring vendor compliance with regulatory and internal standards.
Senior Specialist, Quality Assurance
Cardinal Health
01.2022 - 06.2023
- Handled review of cGMP documentation related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
- Ensured the site manufacture products meeting the requirements of 21 CFR 212 (cGMP).
- Performed product release activities per CGMP requirements, including monitoring and verifying quality control testing of each batch, (utilizing GC, HPLC, dose calibrator, multi-channel analyzer, rTLC plate scanner, analytical balance, PTS, LAFW).
- Managed SAP Inventory (includes inspecting materials, and approving materials for use).
- Engaged and collaborated, provided training, support, and suggestions (performing investigations; monitoring Media Fill simulation; interpreting and contextualizing SOPs, TDAs, CAPAs, guidelines, policies, and controls).
- Provided training and support to operation team.
- Reported quality system issues to the RQM and others as necessary. This includes timely performing investigation and / or escalation of discrepancies upon identification.
PET Lab technician
Cardinal Health
04.2020 - 01.2022
- Manufactured radioactive isotopes (includes synthesis set up, hot cell manipulations, distribution) following Standard Operating Procedures (SOPs) in accordance with cGMP requirements, including GDP.
- Conducted quality control testing of each batch, monitor, and verify quality in accordance with SOPs (utilizing gas chromatograph, dose calibrator, multi-channel analyzer, TLC plate scanner, high-performance liquid chromatograph, analytical balance, PTS, laminar flow hood and fume hood).
- Made product vials and customer vials for use in drug production, conducting environmental and personnel monitoring in ISO 5 environment.
- Coordinated daily production, running schedule based on customer and pharmacy needs.
- Handled review of cGMP documentation related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
- Managed SAP Inventory (includes receiving materials, inspecting materials for use, and maintaining proper cycle counts).
- Demonstrated daily radiation safety tasks, along with general lab cleaning.
- Communicated QA feedback issues to operations Team Leaders & Manager, coordinate closely with team leaders and / or managers on quality performance management.
Graduate Teaching Assistant/Graduate Research Assistant
05.2011 - 12.2021
- Assisted with academic research such as developing synthetic scheme; follow synthesis procedure; collect, and analyze data; organize and plan experimental operations.
- Prepared manuscripts, and other production of academic journal articles.
- Supervised undergraduate students working on assigned research projects.
- Synthesized various type of bidentate ligands and dyes exploring their utility in the areas of solar energy harvesting, photodynamic therapy and sensing.
- Infrared Spectrometer; UV/VIS spectrometer, Fluorescence spectrometer; Nuclear Magnetic Resonance Spectrometer (NMR); Gas Chromatography (GC), High-performance Liquid Chromatography (HPLC); Atomic Absorption; Electrochemical Instrumentation such as Cyclic Voltammetry, Differential Pulse, Rotated Ring-Disk Electrochemistry (RRDE).
- Supervised other Teaching Assistants, including teaching laboratory sections; reading and evaluating experiment procedures; holding a weekly GTA meeting; maintain students’ records.
Composites technician
Senior Aerospace Composites
Wichita, Kansas
08.2006 - 12.2010
- Lead and oversee quality assurance processes for composite manufacturing operations, including fiberglass lay-up, vacuum bagging, and curing processes, ensuring full compliance with internal procedures, customer specifications, and regulatory standards.
- Establish, implement, and continuously improve Quality Management Systems (QMS) aligned with aerospace standards (e.g., AS9100), driving consistency across complex assembly and manufacturing activities.
- Interpret engineering drawings, blueprints, specifications, and process documentation to define quality requirements, inspection criteria, and acceptance standards for composite structures and assemblies.
- Provide strategic oversight of inspection and testing activities, including dimensional verification, non-conformance evaluation, and root cause investigations related to lay-up, drilling, fastening, bonding, and finishing processes.
- Lead cross-functional teams (engineering, production, and operations) to resolve quality issues, implement corrective and preventive actions (CAPA), and improve manufacturing efficiency and product reliability.
- Manage and mentor quality and production personnel, ensuring adherence to standardized procedures, training requirements, and continuous skill development.
- Oversee validation and qualification activities for equipment, tooling, and processes, including vacuum bagging systems, curing cycles, and measurement/testing equipment.
- Ensure proper application and control of materials and processes such as sealants, primers, coatings, and cleaning agents in accordance with quality and safety standards.
- Drive continuous improvement initiatives using data-driven quality metrics, reducing defects, rework, and production variability while enhancing overall product performance.
- Ensure audit readiness and support internal, customer, and regulatory audits, maintaining compliance with aerospace manufacturing and safety requirements.
Dillons’ Clerk
- Prepared Chinese dishes with highest quality meats and vegetables; build attractive displays, stock shelves, and order supplies; ring up purchases, apply sales codes, handle cash/check up to $1,000 daily; offer product suggestions, and answer questions about services and company policies.
Education
Master of Science - Chemistry
Wichita State University
Wichita, KS12-2021
Bachelor of Science - Chemistry
Wichita State University
Wichita, KS05-2013
Skills
- Quality Control
- SOPs, IOPQ, CAPA, SCARs, cGMP, ISO
- Matrix Organization
- Problem Solving
- Critical Thinking
- Teamwork
- Detail-oriented
- Leadership
- Analytical Skills
- Organizational Growth
Publications
- [Ru(bpy)3]Cl2 – Synthesis, Physical and Photophysical Properties, Rillema, D Paul; Cruz, Arvin J.; Nguyen, Huy, J.Chem.Ed.
- HOMO-LUMO Energy Gap Control in Platinum(II) Biphenyl Complexes Containing 2,2’-Bipyridine Ligands, Rillema, D Paul; Stoyanov, Stanislav; Cruz, Arvin J.; Nguyen, Huy
- Study of 1H resonances in cis-(dichloro)ruthenium(II) complexes containing bidentate heterocyclic ligands based on 2,2’-bipyridine, Rillema, D Paul; Nguyen, Huy
- Synthesis And Computational And Experimental Investigations Of A Nicotinic Acid-Bridged Dirhenium (I) Dimer, Stoyanov, Stanislav; Nguyen, Huy; Komreddy, Venugopal; Rillema, D Paul
- Polypyridyl complexes of uracil derivatives attached to 2,2’-pyridyl, Nguyen, Huy; Curtis Moore; Rillema, D Paul
Timeline
Principal Specialist, Quality Assurance- PET
Cardinal Health
06.2023 - Current
Senior Specialist, Quality Assurance
Cardinal Health
01.2022 - 06.2023
PET Lab technician
Cardinal Health
04.2020 - 01.2022
Graduate Teaching Assistant/Graduate Research Assistant
05.2011 - 12.2021
Composites technician
Senior Aerospace Composites
08.2006 - 12.2010
Dillons’ Clerk
Master of Science - Chemistry
Wichita State University
Bachelor of Science - Chemistry
Wichita State University