Summary
Overview
Work History
Education
Skills
Languages
Timeline
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Chun Hsiu Tseng

Vancouver,BC

Summary

Detail-oriented, independent and highly adaptable Manufacturing Technologist with a strong cGMP Right First Time mindset. Skilled in GMP manufacturing processes, including CCR, NCR, CAPA, and SOP revisions. Experienced in leadership roles, including leading change committee meetings and training personnel in finished goods operations. Committed to fostering a collaborative and friendly work environment to ensure compliance and quality.

Overview

9
9
years of professional experience

Work History

Manufacturing Technologist, GMP

STEMCELL Technologies
01.2023 - Current
  • On the floor support of delivering scheduled batches including cleaning of equipment, mixing, filling, and packaging of products.
  • Designated trainer for finished goods.
  • Designated departmental change coordinator.
  • Lead change committee meetings which assess impact, identify gaps, and assign tasks to changes affecting GMP.
  • Lead in requesting and receiving of master batch records (MBR) in accordance with schedule
  • Support MBR reviews and flag resolutions to ensure products are released timely.
  • Taking initiative in continuous improvement programs through consistent 5S, and OFI efforts.
  • Creating, updating, and periodically reviewing cGMP documentation to maintain accuracy.
  • Initiate investigations and conduct root cause analysis in the occurrence of a deviation and recommend CAPAs when applicable.

Internship Student

National Taiwan University
06.2016 - 08.2016
  • Assisted Masters and PhD students in carrying out research procedures at a cancer research laboratory.
  • Quickly gained proficiency in a range of laboratory techniques, including cell culture, PCR, Western blotting, and chemiluminescence immunoassays.
  • Delivered a presentation on key learnings and experiences gained during the internship.

Education

Bachelor of Science - Cellular And Molecular Biology

University of Toronto
Toronto
05-2022

Skills

  • Right First Time
  • Change Control
  • Deviations
  • Manufacturing Processes
  • CAPAs
  • Standard Operating Procedure (SOP)
  • ERP Systems
  • QMS
  • Teamwork and collaboration
  • Leadership
  • Problem-solving
  • Attention to detail

Languages

English
Native or Bilingual
Chinese (Mandarin)
Native or Bilingual

Timeline

Manufacturing Technologist, GMP

STEMCELL Technologies
01.2023 - Current

Internship Student

National Taiwan University
06.2016 - 08.2016

Bachelor of Science - Cellular And Molecular Biology

University of Toronto

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Chun Hsiu Tseng