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Edgar Quinonez is listed as FDA Compliance Consultant @ Gabe, Inc.® | Drug Product Registration at Gabe, Inc.®, a company with 55 employees, based in United States, United States, United States. AeroLeads shows a matched LinkedIn profile for Edgar Quinonez.
Edgar Quinonez previously worked as Independent Consultant at Gabe, Inc.® and Regulatory Affairs Specialist at Hyland'S Naturals. Edgar Quinonez holds Google It Support Professional from Coursera, Mountain View, Ca.
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As an Independent Consultant at Gabe, Inc.®, I leverage my extensive knowledge and experience in navigating the FDA's CDER Direct Electronic Submission Portal to provide guidance and support to pharmaceutical sector stakeholders. With over seven years of regulatory compliance and documentation control expertise, I help clients achieve precise and compliant drug product registration and listing, ensuring alignment with evolving standards and best practices.I collaborate with clients to spearhead the initiation and execution of meticulous registration processes for innovative drug products, leveraging the advanced functionalities and protocols of the FDA's CDER Direct Electronic Submission Portal. I also conduct in-depth analyses and systematic revisions of prevailing drug product entries, ensuring accuracy and quality. Additionally, I manage the reservation and allocation of NDC numbers, and seamlessly coordinate with diverse stakeholders to ensure regulatory conformity and operational efficiency. My mission is to facilitate the safe and timely delivery of life-saving and life-enhancing products to the market.
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Irvine, California, United States
- Collaborating with pharmaceutical sector stakeholders, providing guidance on navigating the FDA CDER Direct Electronic Submission Portal for precise and compliant drug product registration.- Spearheading the initiation and execution of the meticulous registration process for innovative drug products by leveraging the advanced functionalities and.
Los Angeles, California, United States
- Collaborated with the Chief Pharmacist to manage the processing of reports related to complaints, accidental ingestions, and adverse events, ensuring thorough and timely resolution.- Conducted efficient and accurate data entry for product complaints and adverse events into the Master Control software, facilitating the prompt reporting of findings..
Los Angeles, California, United States
- Edit information cards and ensure the seamless upload of documents and attachments within the Master Control system, overseeing the accurate tracking of essential records.- Administer the addition of reviewers to routes in Master Control, reviewing and electronically launching change control requests, and meticulously tracking document revisions and.
Vernon, California, United States
- Orchestrated collaborative efforts with the Graphic Department to curate and update artwork files, meticulously examining final artwork for precision and completeness.- Implemented adjustments to artwork files, conducting annual evaluations for the endorsement of artwork proofs while maintaining seamless communication with external commercial printing.
Vernon, California, United States
- Diligently conducted comprehensive inspections of production lines both before and after each production lot, ensuring thorough line clearance in strict adherence to rigorous quality standards.- Simultaneously oversaw and meticulously audited packaging operations across multiple production lines, assuring the flawless execution of protocols and stringent.
California, United States
- Diligently oversaw and managed the documentation review process to ensure meticulous compliance with Quality Management System (QMS) standards, FDA regulations, and exercising consistent vigilance in monitoring and maintaining accuracy.- Acted as a pivotal liaison with the Research and Development team, playing a key role in the creation and development.
Irvine, California, United States
- Fostered effective communication and collaboration with external calibration entities, establishing robust partnerships to ensure stringent adherence to calibration standards and seamless operational alignment.- Orchestrated the calibration database system, meticulously generating and overseeing calibration work orders, while rigorously curating and.
Lynwood, California, United States
- Facilitate the authorization and execution of line clearance procedures, ensuring the seamless initiation of production activities and the strict adherence to regulatory guidelines and company-defined protocols for operational excellence.- Rigorously inspect and grant approval for the receipt of various printed materials, encompassing labels, unit.
Other employees you can reach at gabeinc.com. View company contacts for 55 employees →
Jennie Harvey
Colleague at Gabe, Inc.®Esbon, Kansas, United States, United States
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Madeleine Spector
Colleague at Gabe, Inc.®Los Angeles Metropolitan Area, United States
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Taylor Campos
Colleague at Gabe, Inc.®Simi Valley, California, United States, United States
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Neeley Humphrey
Colleague at Gabe, Inc.®Cincinnati, Ohio, United States, United States
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Beth Nixon
Colleague at Gabe, Inc.®Morgantown, West Virginia, United States, United States
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Sally Bates
Colleague at Gabe, Inc.®Fairmont, West Virginia, United States, United States
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Gabe Balasquide
Colleague at Gabe, Inc.®Cincinnati Metropolitan Area, United States
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Cody Joost
Colleague at Gabe, Inc.®Thousand Oaks, California, United States, United States
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Rae Sawyer
Colleague at Gabe, Inc.®Holcomb, Missouri, United States, United States
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Wade Floyd
Colleague at Gabe, Inc.®Bellingham, Washington, United States, United States
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Quick answers generated from the profile data available on this page.
Edgar Quinonez works for Gabe, Inc.®.
Edgar Quinonez is listed as FDA Compliance Consultant @ Gabe, Inc.® | Drug Product Registration at Gabe, Inc.®.
Edgar Quinonez is based in United States, United States, United States while working with Gabe, Inc.®.
Edgar Quinonez has worked for Gabe, Inc.®, Hyland'S Naturals, Continental Vitamin Co Inc, Alacer Corp Foothill Ranch, and Nexgen Pharma.
Edgar Quinonez's colleagues at Gabe, Inc.® include Jennie Harvey, Madeleine Spector, Taylor Campos, Neeley Humphrey, and Beth Nixon.
You can use AeroLeads to view verified contact signals for Edgar Quinonez at Gabe, Inc.®, including work email, phone, and LinkedIn data when available.
Edgar Quinonez holds Google It Support Professional from Coursera, Mountain View, Ca.
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