Zulma Sanchez

Experience

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  Self

  Jan 1994 - now

  Tutor

  -Tutoring in Science (Chemistry, Physics, Biology), Math, English, Spanish at all levels including university (bachelor) and for College Board test-Design and Proof reading of school and university (bachelor level) projects

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  Novartis Consumer Health

  Sept 1999 - Jan 2016

  QC Analyst

  QC Analyst:*Conducted deviation and laboratory investigations *performed complaint investigations *Reviewed data *Managed projects *Wrote and approved validation and qualification protocols and reports *Executed and reviewed method validations *Qualified equipment *Performed methods transfer testing, training and audit *Trained personnel *LIMS Superuser *Lead 5S implementation and sustain phases *Created and revised Procedures * In charge of QC laboratory equipment and instrumentation Preventive Maintenance and Calibration program (schedule all PM, repair, calibration, and qualification services internal and external; review the data generated, archive the records, request quotes and create purchase orders) *Lead and managed IQ/OQ/PQ activities *Coordinated calibration and preventive maintenance activities *Reviewed procedures against USP/NF and EP pharmacopoeias *Calibrated instruments and equipment *Managed contracts and scheduled validations, calibrations, maintenance, repair and construction services *Purchased equipment and supplies *Coordinated work within laboratory and with contractors *Performed testing on raw materials and finished products *Prepared and standardized solutions *Performed sampling of bulk products *Participated in the creation of templates for laboratory notebooks and logbooks, and preparation and binding of the same as a strategy to reduce testing turnaround times and documentation errors. Show less

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  GSK

  Nov 2015 - Sept 2019

  Quality Control Chemical and Microbiology Laboratories Data Review:*Reviewed data (including microbiology) for raw materials, packaging components and finished products complying with testing turnaround times and right the first time standards *Trained personnel *LIMS Superuser *Lead 5S sustain phase *Created and revised Procedures Complaints, PQR/APR, CAPA, Deviations, Change Controls, Laboratory Investigations:*Lead and created Annual Product Quality Reviews *Reviewed and approved deviation and laboratory investigations *Lead the investigation of complaints to assure on time completion of investigations *Trained personnel *LIMS and Empower Superuser

  • QC Reviewer

    Dec 2017 - Sept 2019

  • Quality Systems Specialist

    Nov 2015 - Dec 2017
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  ISPV- Amgen

  Jan 2020 - Jan 2021

  Manufacturing Specialist
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  ISPV - Amgen

  Jan 2021 - Mar 2023

  Supply Chain Manager
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  Catalent Gene Therapy- PharmaBio Serv

  Nov 2022 - Aug 2023

  QA Specialist-Batch Disposition
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  Janssen- QRC Group

  Oct 2023 - now

  QC Investigator

  Manage Laboratory Investigations.