Gilbert Jimenez

Gilbert Jimenez Email and Phone Number

Pharma/BioTech /Medical Device Expert at Quality and Manufacturing Leadership
Gilbert Jimenez's Location
Los Angeles, California, United States, United States
Gilbert Jimenez's Contact Details

Gilbert Jimenez personal email

n/a
About Gilbert Jimenez

 Expertise in Pharmaceutical-Biotech Quality and Manufacturing Systems/Project Management//Nonconformance Investigations/Validation Project Management/Quality Systems Management/Regulatory Risk Management/CAPA Management/Six Sigma Green-Lean Certified/Personnel Management

Gilbert Jimenez's Current Company Details

Pharma/BioTech /Medical Device Expert at Quality and Manufacturing Leadership
Gilbert Jimenez Work Experience Details
  • Beckman Coulter Diagnostics, Danaher Corporation
    Senior Quality Assurance Engineer
    Beckman Coulter Diagnostics, Danaher Corporation Aug 2015 - Nov 2018
    Chatsworth, California
    ● Applied problem-solving methodologies, risk analysis identification, prioritizing, communicating, audit preparations and resolving quality issues relating to the manufacture of Urine Analysis Instruments using Kaizen and Six Sigma/Green Belt tools ensuring compliance to CFR 820 & ISO 13485 ● Reliability validation to new product design-writing and executing protocols cross functionally with Engineering and Quality Management as it associates to change control, documentation issuance, and product specification● Managed calibrated measuring devices, reviewing and approving Out of Tolerances (OOTs) ● As a Certified Auditor lead audits for medical devise facility as it relates to CFR-820 and ISO-13485. ● Supply Management of incoming stock for Receiving/Inspection using statiscal analysis placing items on Dock to Stock status or removing as necessary as per Six Sigma and CFR requirements● Led Quality Assurance team ensuring with daily communications as they relate improvement projects ● Completed Audits to International Field Service Engineers to CFR
  • Baxter Healthcare
    Pharmaceutical Quality Supervisor
    Baxter Healthcare 2009 - 2014
    Audit and improve compliance issues in biopharmaceutical.Led team of 5 Quality Associates on multiple shiftsContinuous Improvement Leader using Six Sigma/Green Belt, LEAN, DMAIC methodologies with cross functional teamsChange ControlProduct Release management
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  • Baxter Healthcare
    Quality/Validation Engineer Ii
    Baxter Healthcare 1999 - 2009
    Greater Los Angeles Area
    Manage process for non conformance reports (NCR)Led Quality Improvement Projects using DMAIC, Value Stream mapping and Standard Work toolsFirst line quality approval for non conformances and corrective actionsRecommended and participated in cross functional teams for CAPA closuresReport Quality Metrics to Senior Mgt TeamApprove Out of Limits from Microbiology Investigated and wrote reports associated to customer complaintsDesigned, wrote and approved validation protocols for a CFR regulated Pharmaceutical process including the process equipment and facility. Process validationCleaning validationProcess parameters evaluated using Failure Mode Evaluation AnalysisEstablishing statistical analysis for decision making tools for bio tech processing
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Gilbert Jimenez Skills

Gmp Capa Validation Pharmaceutical Industry 21 Cfr Part 11 Computer System Validation V&v Fda Cleaning Validation Sop Gxp Change Control Glp Quality System Biopharmaceuticals Quality Auditing Technology Transfer Lims Six Sigma Cross Functional Team Leadership Manufacturing Continuous Improvement Quality Assurance Dmaic

Gilbert Jimenez Education Details

Frequently Asked Questions about Gilbert Jimenez

What is Gilbert Jimenez's role at the current company?

Gilbert Jimenez's current role is Pharma/BioTech /Medical Device Expert at Quality and Manufacturing Leadership.

What is Gilbert Jimenez's email address?

Gilbert Jimenez's email address is gi****@****ter.com

What is Gilbert Jimenez's direct phone number?

Gilbert Jimenez's direct phone number is +132129*****

What schools did Gilbert Jimenez attend?

Gilbert Jimenez attended California State University-Los Angeles.

What skills is Gilbert Jimenez known for?

Gilbert Jimenez has skills like Gmp, Capa, Validation, Pharmaceutical Industry, 21 Cfr Part 11, Computer System Validation, V&v, Fda, Cleaning Validation, Sop, Gxp, Change Control.

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