Janet Gonzalez Email & Phone Number | Over 20 years of experience within the pharmaceutical QA/QC and IT Quality environments; evaluating GxP digital software solutions, implementing, configuring, validating, managing projects, administration, and ensuring compliance of electronic computer systems / computerized quality systems and data integrity. Six Sigma, Project Manager Professional (PMP). In charge and responsible for the: * GxP Quality Control/Quality Assurance computerized systems at Noven Pharmaceuticals, Schering Plough LPO operations and Ivax Pharmaceuticals. * Quality Control laboratory instrument, equipment calibration, qualification, troubleshoot and PM at Ivax Pharmaceuticals * IT Business Partner / Liaison for Quality Assurance/ Quality Control and Product Development for Noven Pharmaceuticals Entrepreneur -- Introduced a new OTC health product in to the Puerto Rico market; all stages of a new product introduction from product import to marketing, start up business registration. -- Imported FDA Approved OTC Drug from Indonesia to Puerto Rico, experienced dealing with the Puerto Rico Department of Health, Drug Registration and business registration Consultant providing services on the below specialties Specialties: Pharma-Biotech /Medical Device, Analytical Chemistry, GMPs, GxP Applications, IT Business Partner, FDA regulation, 21 CFR Part 11 Assessments, Data integrity, GAMP5, GxP System Life Cycle (SDLC, SLC), Computer Systems Validation, Quality Process Improvements, Electronic or Computerized Quality Systems Installation, Configuration, Compliance, Project Management, Administration, Training and Troubleshooting, Investigations and CAPA systems, effectiveness checks, audits/assessments, equipment qualification and calibration, SOP's, FDA 483 responses, Consent Decree Remediation, Process Assessments, Root Cause Analysis. Quality Systems, Stability, Team Building, Technical Writing, Digital Transformation. Implemented & Validated: LabWare, Sample Manager LIMS, SQL*LIMS, UL Eduneering ComplianceWire LMS, Waters Empower, TrackWise, Documentum, FirstDoc, Master Control, Totalchrom, Calibration Manager, and standalone systems such as HP Chemstation, Nicolet Omnic, Datapro TOC, Windox, NuGenesis Archive, Rees Centron SQL EMS, others. SQL Cluster, Citrix Xen App Farms, Windows Servers IQ/OQs. ERP-LIMS integration. QC Instrument and Equipment Qualification, Calibration, Troubleshoot & PM (HPLCs, TOC, Particle Size Analyzers, Polarimeters, Diss Baths, FT-IR, UV, others) Global Senior Product Manager LIMS and ELN Software Solutions for Quality Control & Manufacturing

Janet Gonzalez

Over 20 years of experience within the pharmaceutical QA/QC and IT Quality environments; evaluating...
Fort Lauderdale, Florida, United States

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Janet Gonzalez’s Email janet.g@abbott.com

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Janet Gonzalez’s Location Fort Lauderdale, Florida, United States

Janet Gonzalez’s Current Industry It Compliance Solutions

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Work Experience

It Compliance Solutions

IT GxP Digital Quality Compliance Senior Consultant

2023-04-01 00:00:00 - Present

Starlims

Senior Product Manager, STARLIMS Quality Manufacturing

2022-03-01 00:00:00 - 2023-06-01 00:00:00

Abbott Laboratories

Sr Product Manager, Quality Manufacturing/Environmental Science, Abbott Informatics n

2015-02-01 00:00:00 - 2022-03-01 00:00:00

Noven Pharmaceuticals

Director Track/Senior Manager, Electronic IT Quality Systems

2014-01-01 00:00:00 - 2015-02-01 00:00:00

Schering Plough

IT Compliance Analyst/System Administrator

2002-03-01 00:00:00 - 2005-08-01 00:00:00

J Gonzalez

Entreprenuer

2003-03-01 00:00:00 - 2005-08-01 00:00:00

Ivax Pharmaceuticals Caribe

QC System Analyst/Calibration Specialist/System Administrator

1995-03-01 00:00:00 - 2002-03-01 00:00:00

Amigo Supermarket

Front-End Asst. Manager

1985-04-01 00:00:00 - 1996-06-01 00:00:00

University Of Puerto Rico

General Chemistry Laboratory Instructor

1993-01-01 00:00:00 - 1994-01-01 00:00:00

Skills

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FAQ About Janet Gonzalez

Janet Gonzalez is located at
Fort Lauderdale, Florida, United States

Janet Gonzalez is a Over 20 years of experience within the pharmaceutical QA/QC and IT Quality environments; evaluating GxP digital software solutions, implementing, configuring, validating, managing projects, administration, and ensuring compliance of electronic computer systems / computerized quality systems and data integrity. Six Sigma, Project Manager Professional (PMP). In charge and responsible for the: * GxP Quality Control/Quality Assurance computerized systems at Noven Pharmaceuticals, Schering Plough LPO operations and Ivax Pharmaceuticals. * Quality Control laboratory instrument, equipment calibration, qualification, troubleshoot and PM at Ivax Pharmaceuticals * IT Business Partner / Liaison for Quality Assurance/ Quality Control and Product Development for Noven Pharmaceuticals Entrepreneur -- Introduced a new OTC health product in to the Puerto Rico market; all stages of a new product introduction from product import to marketing, start up business registration. -- Imported FDA Approved OTC Drug from Indonesia to Puerto Rico, experienced dealing with the Puerto Rico Department of Health, Drug Registration and business registration Consultant providing services on the below specialties Specialties: Pharma-Biotech /Medical Device, Analytical Chemistry, GMPs, GxP Applications, IT Business Partner, FDA regulation, 21 CFR Part 11 Assessments, Data integrity, GAMP5, GxP System Life Cycle (SDLC, SLC), Computer Systems Validation, Quality Process Improvements, Electronic or Computerized Quality Systems Installation, Configuration, Compliance, Project Management, Administration, Training and Troubleshooting, Investigations and CAPA systems, effectiveness checks, audits/assessments, equipment qualification and calibration, SOP's, FDA 483 responses, Consent Decree Remediation, Process Assessments, Root Cause Analysis. Quality Systems, Stability, Team Building, Technical Writing, Digital Transformation. Implemented & Validated: LabWare, Sample Manager LIMS, SQL*LIMS, UL Eduneering ComplianceWire LMS, Waters Empower, TrackWise, Documentum, FirstDoc, Master Control, Totalchrom, Calibration Manager, and standalone systems such as HP Chemstation, Nicolet Omnic, Datapro TOC, Windox, NuGenesis Archive, Rees Centron SQL EMS, others. SQL Cluster, Citrix Xen App Farms, Windows Servers IQ/OQs. ERP-LIMS integration. QC Instrument and Equipment Qualification, Calibration, Troubleshoot & PM (HPLCs, TOC, Particle Size Analyzers, Polarimeters, Diss Baths, FT-IR, UV, others) Global Senior Product Manager LIMS and ELN Software Solutions for Quality Control & Manufacturing

Janet Gonzalez currently works in the It Compliance Solutions |

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Janet Gonzalez has prior
experience in the following industries:
Starlims | Abbott Laboratories | Noven Pharmaceuticals | Schering Plough | J Gonzalez | Ivax Pharmaceuticals Caribe | Amigo Supermarket | University Of Puerto Rico

Janet Gonzalez has the following professional experience:
It Compliance Solutions | Starlims | Abbott Laboratories | Noven Pharmaceuticals | Schering Plough | J Gonzalez | Ivax Pharmaceuticals Caribe | Amigo Supermarket | University Of Puerto Rico