Data Analyst Quality Assurance
Resume:
CONTACT
PHONE: +1-213-***-****
EMAIL:
************@*****.***
SKILLS
MS OFFICE, Outlook, Power
Query; Pivot Table, Power BI,
SQL; Excel Interactive Dashboard,
Excel and Data Analysis, Project
Management, Agile Facilitation,
SOP Writing, Laboratory
Investigation, CAPA, Root Cause
Analysis, SOP Writing, Laboratory
Investigation, Root-Cause
Analysis, Project Management,
Agile Facilitation, SAP, GLIMS,
Laboratory Audit, Quality Review
and Release of Materials,
TRACKWISE, LABWARE,
THERMO FISHER,
Chromestation, gLIMS, SAP,
Audit, cGMP, GDP, GLP, ISO
17025, ISO 13485, ISO 9001,
USP, ICH, EP, BP, HPLC, GC,
UV-VIS, LCMS, Laboratory
Equipment Qualification
SEO, WordPress, Digital
Marketing, Product Branding,
Branding Communication, Poster
Design, Video Editing, Canvas
Poster Creation, Google Ads,
Amazon Writing
CERTIFICATE/S COMPLETED
BENIA D. SARTHOU
• Ensuring the highest efficacy, purity, and safety standards for pharmaceutical and medical device products through quality assurance and data analysis
Education
Pamantasan ng Lungsod ng Maynila (University of the City of Manila) Bachelor of Science in Chemistry
Singapore Management University
Graduate Certificate in Communication Management
Work Experience
Archiocese of Los Angeles, USA
Job Title: Parish Office Secretary Bookkeeper
Jan 2025 - Present
Promptly and professionally answered and directed all incoming calls to the appropriate staff member or department.
Diligently recorded and managed all mass intention requests, ensuring accuracy and attention to detail.
Efficiently processed and documented all donations, promptly issuing receipts to donors.
Skillfully and calmly handled various situations and inquiries at the front desk, providing excellent customer service and support. Company: Cook Medical Devices Singapore
Job Title: Quality Assurance Specialist
Aug 2023 – Apr 2024
Led Non-Compliance Incident Reporting in Trackwise for every Customer Complaint received in the Asia market.
Led the development and maintenance of Quality Management System
(QMS) in compliance with ISO 13485. Analyzed data to identify areas for improvement in the quality system.
Investigated customer complaints and non-conformance issues and monitored them to ensure closure.
Led the execution of Corrective and Preventive Action (CAPA) system and monitored to ensure timely closure of complaints.
Issued Investigation Letters to Customers who filed complaints. Verified and documented any defects found during the inspection of products and liaised with Cook Manufacturers.
Performed any product recalls from APAC countries with Cook distribution. Team member of the Site Audit Readiness Team.
Company: Pfizer Asia Pacific, Singapore
Job Title: Quality Control Specialist
December 2021 - Jul 2023
Created GLIMS template for QC Lab personnel to document their laboratory testing results through automation.
Created Master Data in GLIMS (Global Laboratory Information Management System).
Operated LABWARE version 8 of GLIMS.
2 of 2
Data Analytics and Creation of an
Interactive Dashboard Using Python
National Trade Union Centre Learning
Hub Singapore
24 - 31 Jul 2021
Data Analysis Fundamentals Using
Excel
National Trade Union Centre Learning
Hub Singapore
09 Jan 2021
Project Management for All
National Trade Union Centre Learning
Hub Singapore
04 -18 Apr 2021
ICAGILE -AGILE Team Facilitation
National Trade Union Centre Learning
Hub Singapore
12-13 Jun 2021
Apply Workplace Safety and Health
In-Process Plant
National Trade Union Centre Learning
Hub Singapore
Jan 2019
Chemical Safety Awareness
National Trade Union Centre Learning
Hub
Jan 2019
Operationalise the Analytics Models
Lithan Academy Pte Ltd Singapore
Apr – June 2018
Apply Data Visualization (Data
Queries & Visualization Queries
Competency Analytics)
Lithan Academy Pte Ltd Singapore
Jan - Mar 2018
Implement Operations for Service
Excellence
National Trade Union Centre Learning
Hub Singapore
Mar 2014
CPR and AED Safety Management
Sport Singapore
Sep 2018
Microsoft Office Excel Core
National Trade Union Centre Learning
Hub Singapore
Mar – Apr 2013
Project Management Program
Lithan Academy Pte Ltd
Sep 2011
Executed verification testing and reviewed and approved the creation of the GLIMS template.
Company: Reckitt (Mead Johnson) Singapore
Job Title: Quality Assurance Specialist
October 2020 – October 2021
Executed the globally assigned GB China compliance project on Specification for Raw Materials.
Maintained the MASTR (Material and Specifications Testing Report) in GLIMS (Thermo Fisher) for all raw materials.
Led site meetings for the implementation of global projects. Liaised with third-party laboratories.
Participated in the release of materials used in trial batches. Prepared documents needed for regulatory audits.
Team member of the Site Audit Readiness Team.
Joined safety audits.
Assisted in the closure of Change Controls about HACCP controls in the plant.
AWARDEE (5x) by (Mead Johnson) Singapore Plant Leadership Team Organization: GSK Vaccines, Singapore
Job Title: SAP Quality Control Specialist
Dec 2016 – Feb 2020
Responsible for SAP System in QC, which includes coordinating and performing changes in inspection plans and other SAP-related matters. Prepares test methods and specifications using Excel extracted from SAP to be presented during the FDA compliance audit.
Supports the closure of CAPA and Change Control tasks related to SAP Organization: Duke-NUS Graduate Medical School
Job Title: Research Associate
Oct 2013 – May 2016
Processing and running biological samples in AGILENT mass- spectrometer-based analyses of key metabolic intermediates. Performs laboratory the primary protocols for extracting and analyzing lipids, acylcarnitines, amino acids, and organic acids using triple quad LCMS.
Performing data clean-up independently using the mass spectrometer's data analysis software
Company: Merck Sharp and Dohme
Job Title: Incoming Material Chemist
Mar 2008 – Oct 2013
Led timely release and quality data review for production use of incoming materials, including excipients, packaging materials, and intermediate pharmaceutical ingredients. Ensuring that investigation reports are closed, PCR (product change requests) are closed, and micro testing has been performed and passed acceptance criteria.
Led timely closure of investigations by conducting an inspection, interview, root-cause analysis if applicable, writing reports which include background, impact assessment, and CAPA
Led inspection at the Warehouse for every “observation” recorded by the Warehouse. Raise a necessary laboratory investigation thereafter.
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