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Yili X. - 15629 Internal Auditor
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Yili X. - 15629
7:54 PM, GMT -04:00

Yili X. - 15629 Internal Auditor from Toronto

About

Dear Hiring Manager,   Hope you are doing well. It is with great enthusiasm that I am applying for the Internal Auditor posted on LinkedIn. I am confident that, as a productive Sr. Quality Assurance Associate with +9 years of experience in the industry, my excellent review, audit and organization skills, together with hands-on sterile manufacturing microbiologist and R&D experience matched to your requirements.   As a Certified Quality Auditor (CQA), I am currently managing the self-inspection, regulatory audit, vendor and customer audit program. I also oversaw the successful release of clinical products from R&D to sterile manufacturing stage, therefore technically equipped with manufacturing review knowledge of filter adsorption/fill volume /bacterial retention validation, raw material, medial fill, EM, LMS, batch record, AQL inspection, labeling, analytical results, rework, and CoA issuance. Moreover, I usually worked on deviations, laboratory investigations, change control, and CAPA to ensure the timely approval and closure of. I also demonstrated high efficiency in documentation by independently delivered over +50 QA trending reports and +300 EM trending reports which significantly accelerated the KPI by 50%. 
 As a highly-motivated, results-driven and detail-oriented professional, I have advanced my time management and organization talents when running multiple projects at the same time, so I can handle a large workload under a tight deadline.  Each career position has been a new challenge, and I became competent within a short period and was promoted several times. In QA department, I took over 4 important clients’ projects in 2 month, and re-streamlined the QA project management process to better provide support to production. I was then promoted to Sr. QA position for the excellent system improvement skills. In Micro department, I was also promoted to senior position for introducing or redesigning procedures which saved the department budget. At the Cord Blood Stem Cell Bank, I was rewarded as Best Employee for the R&D Achievements in 8 months. At the CRO, I was an entrusted member contributing to the global Top 10 pharmaceutical company clients’ project. I am also a proficient user of Trackwise and Content Manager LIMS software. This time I really would like to seize the opportunity to continue my ultimate career goal in your team and offer my best to find balance between the needs of production and compliance.   I would welcome the chance to speak with you in person or online to further discuss the position and my qualifications. I hope through this opportunity I can learn more and be able to apply my experiences that are valuable to your company. Looking forward for an opportunity to meeting with you. Thank you for your time to review my resume.   Yours sincerely, Yili Xu
Occupation

Internal Auditor

Work experience
2022 - Present
Sr. Quality Assurance Associate
Dalton Pharma Services
2020 - 2022
Quality Assurance Associate
Dalton Pharma Services
2018 - 2020
Microbiologist Level II
Dalton Pharma Services
2016 - 2017
R&D Scientist
Union Stem Cell & Gene Engineering Co., Ltd
2013 - 2015
Pharmacology Researcher
Pharmaron, Inc.
Education
2011 - 2012
University of Edinburgh
Master of Science
2006 - 2010
Northeast Agricultural University
Bachelor of Science
Calendar
July 2022
SU M TU W TH F SA
Available
Unavailable

Skills

Audit
9 Y
Biotechnology
9 Y
CAPA
9 Y
Communication Skills
9 Y
Flow Cytometry
9 Y
In Vitro Studies
9 Y
Rules of Procedure
9 Y
Specifications
9 Y
Teamwork
9 Y
Western Blotting
9 Y

Other skills

AQL
TrackWise

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