Kaitlin (Kaity) Gonzalez

Kaitlin (Kaity) Gonzalez Email and Phone Number

Quality-Driven | Project Management | Automation & Innovation | Continuous Improvements @ Moderna
Boston, MA, US
Kaitlin (Kaity) Gonzalez's Location
Greater Boston, United States, United States
About Kaitlin (Kaity) Gonzalez

An accomplished and results-driven professional with substantial expertise in quality, laboratory analysis, automation, and project management across the biotechnology and pharmaceutical sectors. Experienced in establishing and upholding robust quality systems, spearheading system migrations, and championing continuous improvement endeavors. Demonstrated success in matrix leadership roles across diverse international and functional environments, adeptly managing cross-functional teams, ensuring regulatory compliance, and optimizing workflow efficiencies. Possesses keen analytical and a strategic approach to risk identification and solution development, with a steadfast commitment to continuous improvement, meeting deadlines, adhering to GLP, GCP, and GMP standards, and prioritizing safety.Certification: PG PM - Agile Scrum Master - 2024Lean Six Sigma Green Belt - 2023 Sanofi Manufacturing Systems (SMS) Level I - Practitioner - 2021Lean Six Sigma Yellow Belt - 2019

Kaitlin (Kaity) Gonzalez's Current Company Details
Moderna

Moderna

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Quality-Driven | Project Management | Automation & Innovation | Continuous Improvements
Boston, MA, US
Kaitlin (Kaity) Gonzalez Work Experience Details
  • Moderna
    Moderna
    Boston, Ma, Us
  • Moderna
    Sr. Research Associate, Clinical Biomarker Laboratory, Immuno-Assays & Bio-Analytics
    Moderna Mar 2023 - Present
    Cambridge, Massachusetts, Us
    Supports the Clinical Biomarkers laboratory phase 1 & 2 studies by Independently conducting experiments for various assay platforms including: Flu (HAI), NK Engager (ELISA), and Mpox (MSD). Developed and qualified/ validated multiple assay projects and trained junior RAs. Lead of the Special OPS Safety Committee.• Developed the Laboratory Safety Walkthrough Checklist and committee charter.• Developed a Master Tracker for project and resource management that has been used across most assay teams.• Co-Tech Lead of 2 clinical studies and Technical Lead of 2 clinical studies from assay development to sample testing.• SME for the development of the first end-to-end automation HAI assay for Moderna and Phase 2 study live virus.
  • New England Precision, Llc.
    Quality Assurance Manager
    New England Precision, Llc. Jan 2023 - Present
    Develops, improves, and monitors the activities and resources related to implementation and maintenance of effective quality systems including but not limited to: document control, CAPA related issues, calibration certification authoring, invoicing, quotes, and internal and regulatory audits and inspections. Institutes best-practice procedures for compliance and risk mitigation utilizing ISO 17025 and ISO 9001 guidelines.• Leads system migration for all documentation from paper to digital system• Employs Six Sigma tools & techniques for maximization of workflow efficiencies during new company acquisition and bring continuous improvements• Authoring and revising SOPs for a new a quality manual • Coordinates efforts leading to the acquisition and maintenance of appropriate accreditations, licenses and certificates relevant to the industry
  • Sanofi
    Senior R&D Laboratory Analyst- Vaccines
    Sanofi Sep 2022 - Mar 2023
    Paris, France, Fr
    Supports R&D: Global Clinical Immunology department with clinical studies for Influenza vaccine development through ELISA testing, via microneutralization and hemagglutination inhibition assays, as well as MDCK cell culture. Assigned testing in BioSafety level 2 lab using single and multi-channel pipettes, centrifuges, waterbaths, plate washers, biological safety cabinets, and more. Daily maintenance, calibration, and cleaning of equipment. Executes daily transactions in relevant cGMP computer-based systems (NuGenesis, LIMS, Softmax, SUE, etc.). Assist in management of colleagues’ daily tasks and overall lab flow. • Created and manages multiple inventory & tracking systems including: clinical sample inventory, testing assay tracking, sample retest tracking, and stock inventory.• Subject matter expert in the Phase 1 & 2 implementation of the department electronic +QDCI board for performance tracking, in less than 7 months.• Championed the use of automation by innovating an optimized method for LIMS sample scanning using QR codes, increasing the clinical testing department’s efficiency by 400+% and utilized cross-functionally in the data and systems team for use in SQL*LIMS and StarLIMS.
  • Yoh, A Day & Zimmermann Company
    R&D Laboratory Analyst Ii
    Yoh, A Day & Zimmermann Company Apr 2022 - Sep 2022
    Philadelphia, Pa, Us
    *Contracted to Sanofi Pasteur
  • Yoh, A Day & Zimmermann Company
    R&D Laboratory Analyst I
    Yoh, A Day & Zimmermann Company Oct 2020 - Apr 2022
    Philadelphia, Pa, Us
    *Contracted to Sanofi Pasteur
  • Dsm
    Quality Control Lab Analyst
    Dsm Aug 2018 - Mar 2020
    Heerlen, Limburg, Nl
    Conducted Wet Chemistry tests and investigated OOS results for 4 labs. Analyzed raw materials, intermediates, stability samples and finished products. Prepared standards, mobile phases, and all necessary reagents for daily testing. Maintained, monitored, and calibrated lab equipment. • Streamlined lab books, in adherence with cGMP, reducing lean manufacturing wastes. • Performed Gage R&R with 3 analysts, determining method and process variability.• Significantly increased productivity by implementing a visual management system. • Cross-trained on-boarded analysts, increasing hands-on-deck across products & reducing TAT. Part of both the Quality Culture Site Team and Site Sustainability Team
  • Penn State University Police
    Fingerprint Technician
    Penn State University Police Sep 2015 - May 2016
    University Park, Pa, Us
    • Fingerprint scanning using the 3M Cogent CS500e Tenprint LiveScan in a non-criminal environment for the purposes of background checks• Fingerprint collection using fingerprint cards• Fingerprint analysis with the help of software as well as manual skills
  • Penn State University Police
    Entomology Research Assistant For Plantvillage
    Penn State University Police Sep 2015 - Jan 2016
    University Park, Pa, Us
    • Research efforts published in Scientific paper • Manipulated thousands of plant images for Google’s Deep Learning program• Organized database of 153 crops & 2,000 plant disease photos & information crop disease detection
  • World In Conversation
    Advanced Facilitator (September-May 2016) & Global Facilitator (January-May 2016)
    World In Conversation Sep 2015 - May 2016
    State College, Pennsylvania, Us
    Navigated effective virtual and face-to-face discussions on race, culture, and global issues. Contributed 8K+ hours in fostering a safe environment for participants’ dialogues.• Incorporated video teleconferencing for NATO cadet training, promoting military-civilian collaborations.• Led 2-day, CIC Summit 3.0 integration practice workshops for 100+ top university students.

Kaitlin (Kaity) Gonzalez Education Details

  • University Of Massachusetts Amherst
    University Of Massachusetts Amherst
    Project Management
  • The Pennsylvania State University
    The Pennsylvania State University
    Science - Class Of 2016

Frequently Asked Questions about Kaitlin (Kaity) Gonzalez

What company does Kaitlin (Kaity) Gonzalez work for?

Kaitlin (Kaity) Gonzalez works for Moderna

What is Kaitlin (Kaity) Gonzalez's role at the current company?

Kaitlin (Kaity) Gonzalez's current role is Quality-Driven | Project Management | Automation & Innovation | Continuous Improvements.

What schools did Kaitlin (Kaity) Gonzalez attend?

Kaitlin (Kaity) Gonzalez attended University Of Massachusetts Amherst, The Pennsylvania State University.

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