Jorge Gonzalez

Chemist and quality professional with 6+ years of experience across pharmaceutical, biopharmaceutical and medical device environments in Puerto Rico, including Amgen, Medtronic, Abbott, Merck, Janssen, AstraZeneca/IPR and Bristol-Myers Squibb. Experienced in GMP Quality Control, QA support, analytical chemistry, HPLC/UPLC, dissolution, method transfer, technical troubleshooting, investigations, CAPA support, change control support, process validation/CSV exposure, controlled documentation and data integrity. Strong working knowledge of cGxP, GDP, ALCOA+, FDA expectations, ISO 13485, 21 CFR Part 11 and quality systems.

Bilingual

English/Spanish, with cross-functional experience supporting Manufacturing, Quality, Engineering, EHS and laboratory operations.

Lab Analyst (Contract) at Johnson & Johnson (Janssen) (2026-01 – 2026-06)

• Completed internal training in complaint handling and quality investigations within Janssen quality systems.
• Performed GMP dissolution testing and laboratory testing supporting manufacturing operations in a high-throughput QC environment.
• Operated and supported analytical instrumentation including HPLC, UV-Vis, FT-IR and dissolution systems in compliance with GMP, GDP and ALCOA+ expectations.
• Used LME and SmartQC workflows to document laboratory activities, manage workload and support execution of assigned analytical tasks.
• Prepared fresh standards, reagents and dissolution media; performed system and run verifications prior to analytical execution.
• Reviewed peer data and verified analytical documentation using laboratory systems including Empower, LIMS and SAP as applicable.
• Identified, documented and escalated laboratory deviations/issues for investigation, CAPA or corrective action support.
• Collaborated with other analysts and reviewers for witness steps, electronic reviews, approvals and GMP documentation completion.

Chemist II – Sensor Fab Laboratory at Medtronic (2023-08 – 2025-02)

• Performed HPLC and UPLC analysis, method development, troubleshooting and technical support in a regulated medical device laboratory.
• Developed Empower methods, calibration curves and custom field configurations to improve analytical execution and data review.
• Supported Process Development/Process Validation (PD), Computer System Validation (CSV) and method validation-related activities using Minitab and regulated documentation practices.
• Managed reagents and materials through SAP and Ariba; implemented QCH/PCH changes through MAP Agile.
• Provided technical guidance, identified laboratory process gaps and created/ supported CAPAs and change orders that improved efficiency, documentation and safety.
• Generated, revised and supported controlled documentation including laboratory instructions, SOP updates, EHS procedures and technical guidance for laboratory practices.
• Created/revised EHS documentation for safe handling of X-ray equipment and dosimeter use; acted as Radiation Safety Officer supporting X-ray certification and compliance with NRC and Puerto Rico Department of Health expectations.
• Conducted LIMS/ELN data integrity reviews and corrected documentation deficiencies in accordance with GLP/GMP expectations.
• Interacted with regulatory agencies for certification and inspection of laboratory X-ray equipment and provided written responses and supporting documentation.

Lab Analyst – Finished Product at Merck by AppleOne (2023-02 – 2023-05)

• Executed content uniformity, dissolution and identification testing using HPLC and ELN systems.
• Ensured data integrity compliance with ALCOA+ and GMP standards.
• Supported instrument calibration and troubleshooting using LabX and eSHOP systems.

Quality Assurance Specialist at Abbott by QRC Group (2022-08 – 2022-10)

• Reviewed and maintained controlled documents including procedures, forms and work instructions.
• Supported CAPA, change management and audit readiness processes.
• Participated in Gemba walks and contributed to quality plan implementation for the Caguas site.
• Collaborated with engineers on complaint review, CAPA investigations and documentation improvements.

Sr. Associate QC – HPLC Drug Product & Drug Substance at Amgen by Snelling Staffing Services (2015-05 – 2017-05)

• Received, inspected, reviewed and processed batch records/EBR-related laboratory documentation in LIMS for in-process and validation samples.
• Performed and reviewed HPLC testing for Drug Product and Drug Substance method transfers, validations and stability programs.
• Ensured complete documentation and data integrity compliance per cGMP, GDP and ALCOA principles.
• Trained laboratory personnel and served as SME for Drug Product method transfer, Empower data processing and technical training.
• Conducted sample testing, standards preparation and compendial/non-compendial methods for QC operations.
• Implemented document revisions including SOPs and test methods; optimized Empower and LIMS templates to improve consistency and efficiency.
• Participated in audits, method validation activities and equipment qualification activities (IQ/OQ/PQ support).
• Led or supported investigations, deviations and CAPA activities; contributed to quality improvement and Lean/6S initiatives.
• Participated in quality process management, equipment preventive maintenance and troubleshooting activities.
• Represented QC on cross-functional teams and followed through on multi-site action items.

Compliance Technical Consultant at AstraZeneca/IPR by Pharma-Bio Serv (2014-04 – 2015-01)

• Conducted purified water and raw material testing including conductivity, TOC, IR, ROI and ID testing.
• Approved test results and released systems for use under GMP.
• Qualified HPLC systems using Chromeleon software and maintained documentation in LIMS.

Independent Consultant at Procter & Gamble by Pharma-Bio Serv (2013-03 – 2013-11)

• Performed daily instrument calibration and documented results.
• Reviewed analytical documentation ensuring compliance with GMP and safety practices.
• Verified chemical waste disposal and calibration record accuracy.

Lab Analyst at Bristol-Myers Squibb by Aerotek (2011-11 – 2012-09)

• Conducted identity and purity testing of raw materials using IR, NIR, UV-Vis, Karl Fischer and pH meters.
• Followed USP/EP methods and SOPs for ROI, LOD and content uniformity testing.
• Supported in-process inspections and data documentation under cGMP guidelines.

Chemistry Researcher at University of Puerto Rico, Mayagüez Campus (2009-08 – 2010-05)

• Isolated and purified hemoglobin proteins from Lucina pectinata via FPLC.
• Analyzed sulfmyoglobin formation kinetics using UV-Vis spectroscopy and Excel modeling.

Bachelor of Science in Chemistry – University of Puerto Rico, Mayagüez Campus (2011)

Medical Sciences Program, Basic Sciences – UMHS St. Kitts/NY/Portland (2017 – 2021)

Radiation Safety Officer Certification – NV5 Training Academy (2023)