Edgar Quinonez Email & Phone Number

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 protocols of the FDA’s CDER Direct Electronic Submission Portal.- Conducting in-depth analyses and systematic revisions of prevailing drug product entries via the sophisticated mechanisms of the FDA’s CDER Direct Electronic Submission Portal, ensuring accuracy and alignment with evolving compliance standards.- Managing the meticulous reservation and allocation of NDC numbers for newly introduced drug products, ensuring precise cataloging and conformity with the regulatory landscape.

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.- Provided comprehensive administrative support to the Adverse Event team and Quality management, meticulously handling the preparation and finalization of Serious Adverse Event documentation submitted to the FDA.- Directed the seamless registration of new drug products on the FDA’s CDER Direct Electronic Submission Portal and oversaw revisions for existing drug products within the platform.- Controlled NDC reservation procedures for new drug products, ensuring compliance by annually reporting drug usage on the FDA CDER Portal in accordance with the CARES Act section 510(j)(3).- Orchestrated the setup of product configurations in WERCSMART (UL) for retail stores, overseeing the precise management and updates of Safety Data Sheets (SDS) for finished goods.- Managed the processing of refund check requests and proactively communicated with customers regarding product returns and refund status, enhancing operational efficiency.

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 updates.- Configure and maintain installations, diligently addressing support issues for timely resolution, collaborating with vendors and internal teams to validate and implement version upgrades promptly.- Administer user accounts while collaborating with process owners to deploy new modules, delivering advanced training to enhance process efficiency and streamline operations.- Produced tailored reports catering to specific user and managerial requirements, ensuring real-time data insights, while also extending support to the Document Control team as needed.- Ensure compliance by submitting and updating drug listings on the FDA’s CDER Direct Electronic Submission Portal, and craft and revise Packaging and Labeling Specification Sheets for internal departments and outsource CMO organizations.- Ensure accuracy and compliance with cGMPs in Packaging and Labeling Specification Sheets, maintain precise records of raw materials in the Supply Chain inventory, and collaborate with Planning and Quality teams to ensure consistency with business software.

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 partners.- Acted as a liaison between document originators, engineers, and management, facilitating the resolution of discrepancies and driving essential document changes within the Documentation and Document Change Control systems.- Spearheaded the creation of new documents as needed, overseeing the Documentation system and managing the Document Change Control system to ensure operational coherence.- Conducted rigorous audits of controlled documents, validating data accuracy and completeness, ensuring mandatory training completion before document rollout.- Directed the coordination and maintenance of training plans, documents, and the Training System, meticulously upholding quality records in accordance with pertinent SOPs.- Contributed to the preparation of Performance Evaluations for annual reviews and oversaw the issuance of Master Batch Records for production, ensuring seamless operational continuity.

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 quality control measures.- Engaged in a rigorous review of in-process manufacturing documentation with painstaking attention to detail, consistently verifying and validating for accuracy and strict compliance with industry standards.- Actively compiled and meticulously validated Batch Records while conducting systematic sampling of incoming Raw Materials, playing a crucial role in guaranteeing the highest quality standards.- Demonstrated unwavering commitment to quality assurance by rigorously verifying Certificates of Analysis (C of A) and associated documentation for incoming Raw Materials, thus ensuring the integrity of the production process.- Employed precision in the measurement and comprehensive documentation of raw material components, contributing to the seamless release and labeling of approved Raw Materials, a pivotal step in production excellence.- Undertook the responsibility of conducting D.I. water testing with a PH meter and meticulously calibrating inspection equipment, thereby upholding the highest standards of operational precision and accuracy.

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 of critical documentation essential for the successful launch and integration of new product lines into the company's portfolio.- Held primary responsibility for the seamless coordination and management of controlled documentation throughout the organization, fostering strong communication channels with external vendors to uphold a cohesive documentation system.- Took charge of the Document Control function within the validated Master Control system, proactively generating necessary new documents, and harmonizing the Documentation and Document Change Control systems for streamlined operations.- Engaged in comprehensive discussions with document originators, engineers, and managerial personnel to effectively resolve discrepancies and ensure the successful implementation of required changes to documents.- Thoroughly reviewed controlled documents, conducting meticulous assessments to verify data completeness and accuracy, while rigorously ensuring that essential training was completed before document implementation for heightened efficacy.- Managed the seamless coordination of training plans, documents, and the Training System, while meticulously upholding quality records in accordance with SOPs and delivering requisite reports to supervisory staff.

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 organizing instrument calibration files to guarantee optimal precision and operational efficiency.- Conducted thorough scrutiny of calibration documentation, overseeing the precise execution of calibration tasks to maintain a high standard of compliance with industry regulations and quality benchmarks.- Implemented and managed approved Change Control procedures, facilitating seamless adaptation to modifications while overseeing the calibration, review, and maintenance of diverse test and measurement equipment to ensure peak performance.- Maintained a vigilant eye on the precise identification of critical instrumentation within the plant, upholding rigorous adherence to quality standards, regulatory requirements, and ensuring the accurate deployment of instruments.- Diligently enforced the "Out of Calibration" status for critical instruments, swiftly flagging and addressing any failures or overdue calibration instances to ensure uninterrupted operational integrity and compliance.- Initiated and oversaw requisite Change Control protocols, ensuring meticulous in-house calibrations were performed with a sharp focus on quality assurance and procedural compliance for sustained operational excellence.

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 cartons, and shrink bands, in order to consistently maintain the highest levels of quality control and uphold the integrity of incoming supplies.- Thoroughly assess and endorse the acceptance of incoming components, meticulously verifying their compliance with stringent quality criteria and regulatory standards to guarantee product integrity.- Methodically categorize labels, unit cartons, and shrink bands in alignment with unique customer brand identities and product nomenclature, establishing an impeccable product presentation that meets the highest standards.- Demonstrate proficiency in overseeing and maintaining master template folders for labels and unit cartons, ensuring efficient organization, quick accessibility, and accurate archiving, thus promoting streamlined operations.- Contribute to the monthly inventory processes, performing meticulous assessments of finalized products to preserve precise stock records, fostering supply chain optimization and enhancing inventory management practices.- Execute a comprehensive review of finished products, meticulously inspecting each item to validate their readiness for shipping, ensuring strict compliance with quality benchmarks and expediting on-time deliveries to customers

Google It Support Professional

High School Diploma

Computer Information Technology, Information Technology, A+