Ariel Gonzalez

Ariel Gonzalez

Denver, Colorado

Overview 

Ariel Gonzalez is a Quality Assurance Specialist at Fresenius Kabi USA, with a background in GMP auditing and document control at Merck. They have expertise in quality systems, CAPA, and the pharmaceutical industry, and hold a Bachelor of Science degree from Penn State University. Ariel has excelled in roles such as GMP Auditor at Merck and Production Technician II at Sandoz, showcasing a strong foundation in quality assurance and pharmaceutical manufacturing. Currently, as a Quality Assurance Specialist at Fresenius Kabi USA, they continue to drive excellence in quality systems and regulatory compliance within the pharmaceutical industry.

Work Experience 

  • Laboratory Manager

    2018 - 2021

    Manage CO2 extraction, distillation, and packaging operations of concentrate manufacturing department producing $900,000 in monthly sales Coordinate with sales, sourcing, and logistics teams in order to make weekly production schedule including laboratory processes, validation, potency testing, filling, packaging, and order fulfillment Forecast and prioritize production needs for individual SKU’s and overall finished goods inventory to ensure 100% order fill rate Manage and order supplies, ensure regulatory compliance, and assist state and city officials during inspections Highly proficient in technical functions including: supercritical carbon dioxide terpene, cannabinoid, and wax/lipid extractions, short-path and wiped film distillation, dilutions, decarboxylation Develop standard operating procedures and batch records

  • Hydrocarbon Extraction and Concentrate Finishing Technician

    2017 - 2018

    Expert finishing of BHO, PHO, and blended extractions into wax and shatter Live resin extraction and finishing into batter or diamonds. Train new finishers in all BHO finishing techniques Forecast production needs and establish schedule priorities Build customer orders and create invoices and manifests using Adilas and Metrc Perform closed-loop hydrocarbon solvent extraction using ETS and EmoTek machines

  • Budtender

    2016 - 2017

    Educate customers about cannabis and guide them to find the best product for their needs Provide excellent customer interactions, execute sales, manage inventory, and check-in patients in Adilas Train new employees

  • Inside Sales Representative

    2014 - 2015

    • Drive positive sales growth by managing a portfolio of over 700 internal customer accounts • Place outbound calls, educate clients, negotiate prices, and manage project research and quotes • Use exceptional interpersonal skills to foster strong customer relationships by providing solutions, education, and guidance • Maintain detailed communication records and analyze sales data and trends

  • Production Technician II

    2012 - 2014

    • Operate, set up, and troubleshoot machinery in pharmaceutical drug manufacturing setting • Improved documentation accuracy metrics by more than 20 percent as member of documentation error remediation team • Led pharmaceutical packaging batch record re-design project and implemented changes for all production lines

  • Quality Assurance Specialist

    2011 - 2012

    • Review in-process batch records in all areas of production and support departments • Audit a variety of production areas in injectable pharmaceuticals facility including: compounding/formulation, component preparation/sterilization, aseptic vial filling, lyophilization, capping, inspection, and packaging areas • Monitor all stages of operations to ensure procedure compliance and product integrity and, if required, designate product for heightened awareness inspection or quarantine • Perform analysis of vial filling operations utilizing statistical process control software

  • Document Control Specialist

    2008 - 2009

    • Manage changes to manufacturing batch record templates and bills of material for final packaging of vaccines and pharmaceuticals • Revise batch records to incorporate manufacturing process changes, custom sections for special runs, and to correct document errors • Coordinate the implementation of new product introductions and launches as part of multi- departmental groups

  • GMP (Good Manufacturing Practices) Auditor

    2007 - 2008

    • Audit source documents in FDA submissions for approval of vaccines and new drugs, including review and approval of production batch records and stability study cumulative reports • Perform internal audits of quality systems and processing areas in the biologics pilot plant to ensure GMP compliance • Manage the stage completion tracking, notification, and closing of Corrective and Preventive Actions (CAPA’s) for investigations • Tested and helped implement new document control software system

Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.

Raised $5,586,000.00 from Private Capital Advisors.

  • Quality Control Technician

    2001 - 2007

    • Perform a wide array of analytical laboratory testing such as: HPLC, dissolution bath, UV and infrared spectroscopy, assay, particle size analysis, pH, viscosity, density, UV/VIS ID, moisture content, and melting range • Review and disposition raw material inspection reports • Inspect raw materials and accompanying documentation for errors and deviations from specifications and SOPs • Identify, investigate, and provide timely resolutions to inventory discrepancies and inquiries in SAP software • Calibrate a wide range of instruments including infrared and UV spectrometers, viscometer, particle size distribution analyzer, moisture analyzer, polarimeter, refractometer, dual-bead diameter gauge, and Zahn cup

Johnson & Johnson is a healthcare provider, expertise in innovative medicine and MedTech for every patient & for everyone.

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