Miranda H.

Experience

• 

  Luminex Corporation

  Mar 2008 - Mar 2018

  Includes the responsibilities from Associate Scientist II plus the following:• Collaborated with Quality Control (QC), Manufacturing, Research & Product Development, Quality Assurance (QA), and Regulatory Affairs departments on multiple projects and product releases.• Collaborated with Suppliers and off site visits to discuss validation/verification plans for products.• Experienced in writing documents for process and product validation which include supplier review, acceptance criteria, protocols and reports. Show less • Designed, implemented and maintained positive controls (Genomic and plasmid based) under cGMP standards. • Collaborated with product development on process improvements and validation of on-market products, ensuring that any changes to product specifications follow regulation and do not impact product performance.• Led product stability program to ensure that the product shelf life met or exceeded requirements. • Authored protocols and reports and worked closely with reviewers/approvers on the design review committee.• Responsible for internal prequalification program to test and report on key reagents from suppliers. Show less Includes the responsibilities from Associate Scientist I plus the following:• Experienced in interpreting results, preparing recommendations and presenting reports using quantitative measures and qualitative data analysis.• Lead responsible for collaborating with PD and Operations on internal prequalification programs to test and report on key reagents from suppliers on two core product lines.• Responsible for the support/troubleshooting/continuous improvement of established manufacturing operations in limit of detection, Robustness and Accuracy studies.• Involved in new product design testing, which includes generating SOPs for quality control testing, review of specifications based on data collected from alpha and beta product testing stages, support and data analysis of robustness, reproducibility, accuracy, and limit of detection studies. Show less • Tested and released in-process and final products. • Facilitated new product transfers of processes from product development into quality control. • Collaborated with product development and operations on internal prequalification programs for testing key reagents from external suppliers.• Assisted in stability studies and product control threshold trending reports and investigations.• Compiled data and generated final reports for product stability.• Trained and mentored new QC technicians and QC Associates. Show less • Responsible for raw material and in-process testing and authored documentation including batch production records in accordance to cGMP.• Performed out of specification investigations and reported any non-conformances or deviations related to raw material and in-process products.• Collaborated with manufacturing and purchasing departments to ensure raw materials were tested, ordered, and received within a timely manner.• Identified possible areas of improvements and updated SOPs in accordance to company policy and regulations.• Increased lab efficiency by improving electronic tracking system for internal QC controls, lab organization of samples, enzymes, supplies and freezer organization in accordance to cGMP and regulations. Show less

  • Scientist I

    Apr 2017 - Mar 2018

  • Associate Scientist I, Design Transfer and Process Engineering

    Apr 2013 - Apr 2017

  • Associate Scientist II

    Apr 2011 - Apr 2013

  • Quality Control Associate

    Jun 2010 - Apr 2011

  • Quality Control Technician

    Mar 2008 - Jun 2010
• 

  Qvella Corporation

  Mar 2018 - Mar 2024

  • Managed, reviewed and approved Change Notifications (CNs), DMR, and DHR, ensuring effective production processes and quality compliance.• Oversaw CAPAs, NCRs, DVRs, and OOSs for prompt resolution, investigations, implementation and owned verification of effectiveness (VoE).• Ensured traceability throughout the entire product design, production, and service for CE marked/IVDD/IVDR, CMDR devices and 21 CFR.• Drove Quality improvements in product and processes while facilitating design transfer. • Represented QA in the Approved Supplier List (ASL) process and Complaint Review Boards.• Lead internal audits under MDSAP and ISO 13458:2016. • Analyzed data for KPIs and prepared Management Review documentation and reports.• Core team for external BSI audits in accordance with MDSAP and ISO 13458:2016. Managed external audit findings.• Owned Product releases for Instrument, Power Supply, Cartridge, and Reagents. Show less • Managed Reagent Operations inventory and production logistics to meet forecast demands and KPIs.• Ensure QMS Production/QC/QA procedures and processes met quality standards for the successful launch of medical device products in the US and Europe.• Scale up production to meet forecast demands, reducing COG and TAT on finished goods.• Performed Internal Audits, investigated and closed CAPA’s, OOS, and NCRs ensuring regulatory compliance/QMS.• Spearheaded gap analysis, risk and impact analysis on QMS processes to reduce risk of non-compliance, CAPAs, and deviations, while improving product and process traceability. • Evaluated and roadmap the implementation of eQMS system as company growth exceeded current QMS method. Show less • Directed and supervised Reagent Production and Quality Control Reagent Departments.• Managed Reagent Operations inventory and production logistics to meet forecast demands and KPIs.• Led collaboration between Research, Product Development, QC/QA/RA in knowledge transfer, production process development and design transfer of reagent product.• Collaborated with third party vendors on material assessments, evaluations, equipment IQ/OQ/PQ.• Developed, validated and implemented Reagent manufacturing processes (Beta, to pilot, to launch processes)• Developed and implemented Reagent Production and Quality Control SOP documentations following the QMS GMP/ISO standard (i.e. DMR, DHF, work instructions, bill of material (BOM), transfer records, reports and protocols)• Implemented environmental monitoring onsite using REES Scientific services.• Developed, optimized, and delivered training materials and sessions to Production and QC personnel to be compliant with QMS standards and for WHMIS/Health and Safety requirements. Show less

  • Quality Assurance Lead

    Oct 2023 - Mar 2024

  • Reagent Production Manager

    Jan 2022 - Oct 2023

  • Reagent Production Scientist

    Mar 2018 - Jan 2022
• 

  Trexo Robotics

  Apr 2024 - Dec 2024

  Quality Assurance Lead

  • Develop, documented and improved the QMS to ensure compliance with FDA, Health Canada, EU MDR • Managed CAPAs, NCRs, Complaints and Change Control processes.• Lead correspondence between Trexo and FDA on Quality issues. • Developed, promoted and implemented Quality culture and training.