Summary
Overview
Work History
Education
Skills
Certification
Transferable Skills And Experienced
Timeline
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Pangchuachu Yang

Hickory,NC

Summary

Quality Assurance III with experience in detailed technical specifications. Offers collaborative style and has outstanding communication skills. Expertise quality injection production fill manufacturing and defect resolution. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Lead Quality Assurance- QA III

Exela Pharmaceutical Company
01.2022 - Current
  • Supported company in maintaining work environment focused on quality, communication, collaboration, integration, and teamwork.
  • Enforced, organized, and maintained work environment and production to meet quality and allow for maximum productivity.
  • Developed reports and materials for key stakeholders related to quality goals, progress and challenges.
  • Investigation and wrote deviation, succinct and clear scripts under tight deadlines.
  • Wrote and maintained detailed internal documentation on developed systems, leading and revising Standard Operating Procedures.
  • Adhered to standardized quality assurance best practices, policies and processes.
  • Mentored and coached team members on QA topics and strategies.
  • Managed and motivated employees to be productive and engaged in work.
  • Accomplished multiple tasks within established timeframes.
  • Cross-trained existing employees to maximize team agility and performance.
  • Supervised day-to-day quality operations team to meet performance, quality and service expectations.
  • Maximized performance by monitoring and analyzed daily activities and mentoring team members to identify areas of improvement and make necessary adjustments.
  • Communicated, developed, and maintained relationships with multidepartmental to identify areas of improvement and make necessary adjustments to keep everyone on same page and working toward established business goals.

Senior Environmental Micro Technician II

Exela Pharmaceutical Company
03.2020 - 01.2022
  • Effectively follow Standard Operation Procedures and company policies. Maintained compliance with regulatory standards and safety requirements.
  • Conduct routine environmental monitoring, including but not limited to surface, active air, passive air, water for injection, weekly, monthly, and personnel. Capture, record, analyze, and archive raw data.
  • Perform duties and responsibilities as requested by Management, supervisor, and Microbiologists II.
  • Manage leadership role in the absence of group lead/supervisor, leading a team of six.
  • Organized and delegated assignments and tasks and verified work quality and completion accordingly.
  • Trained, mentored, and motivated employees to be productive and engaged in work.
  • Accomplished multiple tasks within established timeframes.
  • Resolved team member conflicts, actively listening to concerns and finding appropriate middle ground.
  • Authoring to write Master Document (DMS) and scheduling.
  • In the absence of Quality Assurance, duty to perform pre-line and post-line for production. Part-take in media-fill and scribing. Enforce company polices SOP to meet quality in product and environmental quality.

Phlebotomy Technician

Quest Diagnostics
01.2019 - 03.2020
  • Effective informative communication skill, clerical, patient identifications, order of draws, equipment, test procedures orders and processing, and computer skills
  • Drew blood from veins by vacuum tube, syringe, or butterfly venipuncture methods.
  • Collected blood samples using vacutainer tubes, tourniquets, syringes, butterfly needles, and straight needles.
  • Labeled transfer tubes and followed exact directions for handling and storing specimens for transport.
  • Protected patients by following infection control, sharps disposal, and biohazardous waste disposal procedures.
  • Completed proper sanitation and cleaning of equipment and work areas between patients.
  • Self-motivated, with a strong sense of personal responsibility. Skilled at working independently and collaboratively in a team environment.

Phlebotomy Technician

Blue Ridge Health Care
01.2019 - 03.2020
  • Reviewed patient records for accuracy and completeness. Patient registration, scanning lab results, and processing orders. Effective informative communication skill, clerical tasks, patient identifications, order of draw, equipment, test procedures orders, flu swabs, point of care collection, and processing, Using vacutainer tubes, tourniquets, syringes, butterfly needles, and straight needles. Drew blood from veins by vacuum tube, syringe, or butterfly venipuncture methods. Accurately handling and storing specimens for transport. Follow Policy for infection control, sharps disposal, and biohazardous waste disposal procedures.


Certified Nurse Assistant

Golden Sun Homecare
07.2018 - 01.2020
  • Assist with (ADL) activity of daily living, grooming, eating, Most of all be a part of a family and maintain professionalism.
  • Utilized therapeutic communication, empathy and active listening skills to encourage and develop positive relationships with patients.
  • Promoted good oral and personal hygiene by aiding patients with shaving, bathing, and teeth brushing. Assisted with feeding and monitored intake to help patients achieve nutritional objectives.
  • Delivered individualized patient care by recording vital signs, documenting observations, administering treatments, and evaluating patient needs.



Operation Prep Technician

Exela Pharmaceutical Company
08.2016 - 01.2018
  • Following FDA and current Good Manufacturing Practice (cGMP) per SOP with GDocP.
  • Established positive and effective communication among unit staff and organization leadership, reducing miscommunications, and missed deadlines.
  • Frequently inspected production area to verify proper equipment operation. Identified and resolved unauthorized, unsafe, or ineffective practices. Helped meet changing demands by recommending improvements to business systems or procedures.
  • Sustain prep, clean, and sterile/sanitize clean for clean room environments for ISO grades and cleanroom classification class.
  • Operated Production Line Machines, Autoclave, Depydegeneration, and Sterile Water Pressure Washer Machine, laminar flow hood in high grade cleanroom
  • Oversee total sterilization finish drug product and inspect products in and out flows before shipping to Finish Operation sites. Verified and reviewed Batch Record and logbooks entries completion day to day.

Education

Associate in Art - Nursing

Western Piedmont Community College
Morganton, North Carolina
01.2019

Skills

  • Analytical
  • Quick and Determination learner
  • Flexibility
  • Communication
  • Problem-solving
  • Interpersonal
  • Work under pressure
  • Multicultural sensitivity
  • Environmental adaptivity
  • Strong organize and planning skill
  • Details precision and consistency
  • Reliability and punctuality
  • Independent and team player
  • Virtualization
  • Quality Assurance
  • Root Cause Analysis
  • Technical Writing
  • Mentoring and Training

Certification

  • Basic Life Support (BLS) certified by American Heart Association
  • Certified Nurse Assistant (CNA)
  • Phlebotomist Certificate (CPT, ASPT)
  • Resource Conservation and Recovery Act (RCRA) Training
  • Expert OJT Certification (On The Job Training)
  • Technical Writing Certification

Transferable Skills And Experienced

  • On The Job Training Expert (OJT Expert Certification)
  • Technical Writing Certification
  • Alpha Emerging Leaders Graduated Class 2022-2023
  • MODA-FDC/MODA-EM
  • Lighthouse Worldwide Solutions Configuration
  • Non-Conformance Report (NCR) and Conformance Report
  • Investigation and Deviation Writer
  • Forms, Standard Operation Procedures (SOP), and Work Instructed (WI) Reviewer and Approver.
  • Authorize initiator of Deviation and Occurrence, Forms, Standard Operation Procedures (SOP), and Work Instructed (WI) Quality Revisor.
  • Sensor Risk Assessment (SRA)
  • Blue Mountain Regulatory
  • Outlook and Team
  • Salesforce (DMS/TMS/EQMS)
  • Veeva Vault System
  • Quality systems regulations
  • Team leader/Team Management

Timeline

Lead Quality Assurance- QA III

Exela Pharmaceutical Company
01.2022 - Current

Senior Environmental Micro Technician II

Exela Pharmaceutical Company
03.2020 - 01.2022

Phlebotomy Technician

Quest Diagnostics
01.2019 - 03.2020

Phlebotomy Technician

Blue Ridge Health Care
01.2019 - 03.2020

Certified Nurse Assistant

Golden Sun Homecare
07.2018 - 01.2020

Operation Prep Technician

Exela Pharmaceutical Company
08.2016 - 01.2018

Associate in Art - Nursing

Western Piedmont Community College
Pangchuachu Yang