Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

John Hong

San Diego,CA

Summary

Quality assurance professional known for high standards and consistent results. Extensive experience in identifying and resolving quality issues to maintain top-tier product standards. Reliable team player with focus on collaboration and adapting to evolving project needs. Proficient in quality control processes and detail-oriented analysis.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Quality Assurance Specialist III

Epic Sciences, Inc.
02.2024 - 02.2025
  • Monitored and advised on the performance of the quality management system and departmental activities related to Clinical & Regulatory Requirements (CAP/CLIA, HIPAA, ISO13485)
  • Provided guidance to BioPharma Services, Assay Development, Manufacturing Technical Transfer, & Lab Operations to ensure compliance with established standard operating procedures and regulations on a day-to-day basis
  • Provided oversight on change controls regarding policies, procedures, and improvement activities to ensure compliance with applicable regulations
  • Performed internal audits on a routine schedule to ensure procedures and personnel are compliant with CAP/CLIA, ISO13485, and FDA 21 CFR 820 regulations. Discussed findings with key stakeholders and assign actions as needed to address any areas in need of improvement
  • Led quarterly/monthly Quality meetings by analyzing data across key areas of the business (Lot release, Nonconformance, Deviation, and CAPA metrics), identifying trends through root cause analyses, and reporting on performance against set indicators.
  • Monitored and scheduled training/competency checks of 60+ staff members to assure compliance with regulatory standards.
  • Responsible for review and approval of batch records, labeling of material and lot release for a wide range of products. Average of 60+ lots released per month with a turnaround time of 1-2 days
  • Led compliance programs including reviewing and approving Deviations, Nonconformance reports, CAPAs and Audit reports. Held weekly MRB/DRB meetings with key stakeholders to ensure all required actions were completed in a timely manner.

Supervisor, Quality Control

Thermo Fisher Scientific/Mesa Biotech
10.2022 - 06.2023
  • Developed and delivered multiple technical reports on stability studies, summarizing interim results in preparation for site-decommissioning, collaborating with cross-functional teams
  • Deployed a robust logging system to track product retains for future customer complaint investigations, facilitating post-site closure analysis and ensuring data integrity
  • Executed numerous Corrective and Preventive Actions (CAPAs) over six months, resulting in substantial enhancements in product quality
  • Championed initiatives to elevate product quality, including conducting recurrent training programs and optimizing lab layout following 5S methodologies
  • Played a pivotal role in instituting a comprehensive Kanban system across four lab locations
  • Introduced a robust attribute board to fortify Quality standards and concurrently revised Standard Operating Procedures (SOPs) to integrate attribute board utilization across the organization
  • Communicated project outcomes to the Executive Leadership Team through daily and weekly reporting, utilizing Excel to present data via dynamic rolling charts, facilitating the identification of both positive and negative trends
  • Fostered cross-departmental collaboration for NPI programs, collaborating with Quality Engineering, R&D, Manufacturing, and Quality Assurance to ensure compliance
  • Approved and reviewed Out of Specification (OOS) reports essential for Non-Conforming Material Reports (NCMRs) and CAPAs
  • Directed weekly PPI (Process Performance Improvement) sessions with the core team to enhance all facets within the department
  • Averaged 10-12 process improvements monthly
  • Ensured proper scheduling of CALs/PMs for over 100 pieces of equipment

Sr. QC Scientist / Team Leader, Quality Control

Thermo Fisher Scientific/Mesa Biotech
10.2021 - 10.2022
  • Managed Stability, Validation, and NCMR testing, promptly escalating any out-of-specification results to management
  • Optimized newly established Stability Protocols for enhanced efficiency
  • Summarized outcomes from special testing for informative reporting to management
  • Performed change orders as required for SOPs and QCTPs
  • Conducted documentation reviews for high-level testing
  • Investigated any Out of Specification (OOS) instances for products not meeting QCTP standards
  • Produced daily, weekly, and monthly metrics reports
  • Coordinated team schedules effectively across multiple campuses to meet business requirements
  • Instituted a daily audit-readiness checklist to ensure labs were consistently prepared for audits
  • Resolved laboratory challenges with advanced knowledge of SOP/QCTP
  • Organized weekly Practical Process Improvement meetings with upper management to drive continuous workflow enhancements

QC Scientist II

Thermo Fisher Scientific/Mesa Biotech
02.2021 - 10.2021
  • Conducted thorough document reviews and implemented change orders for SOPs/QCTPs as necessary
  • Maintained an average of 3-4 product dispositions to meet daily metrics
  • Summarized weekly metrics for review by management
  • Completed specialized testing for Stability, Validation, and NCMR assessments
  • Performed in-process and final release testing on PCR machines in BSL-2 environments
  • Ensured inventory levels were well maintained on a weekly basis
  • Contributed to resolving obstacles with intermediate knowledge of SOP/QCTPs
  • Actively engaged in the PPI program, implementing an average of four process improvement plans monthly to optimize workflow efficiency
  • Analyzed QC data to support customer complaint investigations and aided Quality Engineers in additional inquiries

QC Associate

Quidel Cardiovascular
06.2018 - 12.2020
  • Conducted daily testing of in-process and final release materials
  • Provided support for special testing from various departments as required (validation, investigational, stability)
  • Executed QC Area Clearance, ensuring compliance with cGMP/cGLP standards for all equipment used
  • Assisted in keeping labs well stocked with reagents/supplies
  • Trained new employees as needed
  • Inspected incoming raw materials to ensure adherence to quality standards
  • Performed Batch Record reviews

Education

Bachelor of Science - Human Biology

University Of California, San Diego
San Diego
06.2016

Skills

  • Internal audits
  • Audit reports
  • Quality documentation
  • Non-conforming material reports
  • Risk management
  • Root-cause analysis
  • Failure modes and effects analysis
  • Corrective and preventive actions
  • Process change documentation
  • Performance metrics

Certification

ISO 13485:2016 Lead Auditor (TPECS) - BSI Group America INC

Timeline

Quality Assurance Specialist III

Epic Sciences, Inc.
02.2024 - 02.2025

Supervisor, Quality Control

Thermo Fisher Scientific/Mesa Biotech
10.2022 - 06.2023

Sr. QC Scientist / Team Leader, Quality Control

Thermo Fisher Scientific/Mesa Biotech
10.2021 - 10.2022

QC Scientist II

Thermo Fisher Scientific/Mesa Biotech
02.2021 - 10.2021

QC Associate

Quidel Cardiovascular
06.2018 - 12.2020

Bachelor of Science - Human Biology

University Of California, San Diego

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