Quality Assurance Management

Eldon Kao, B.Sc. (Hons.), PMP

** ******** **. **** **** ● Toronto, Ontario M2K 3E2 ● 416-***-****

actko4@r.postjobfree.com ● ca.linkedin.com/in/eldonkao ● eldonkao.com

PERSONAL PROFILE

Continuous Improvement professional specializing in Project Management, Change Management, Process Engineering, and Lean Six Sigma with broad industry experience including front-end and back-end process assessment. Proven problem solving and investigative skills with ability to rally and be the arbiter for cross-functional teams.

SUMMARY OF QUALIFICATIONS

Over 3 years of CI/Lean Six Sigma working experience in progressive roles

Lead and project managed multiple CI projects with teams of up to 15 members using DMAIC, PDCA cycle methodology

Experience writing detailed CI/QA related reports including: project summaries, deviation and complaint investigations, CAPAs, CAPA effectiveness reviews, change controls, SOPs/WIs, Quarterly trending reports

Working knowledge of LIMS, SAP, Radius, TrackWise, Oracle/ERP, CMMS, Statgraphics, MS Word, Access, Excel, PowerPoint, Outlook, Visio, and Project

Experience with various CI tools and techniques including: VSM, visual management, 5S, A3, poka-yoke, kanban, kaizen, SWOT, FMEA, SMED, Time and Motion analysis, etc.

PROFESSIONAL EXPERIENCE

Regional Lean Specialist (Toronto, New Jersey, New York)

Multi Packaging Solutions, Toronto, ON 05/2015 – present

Oversee and manage Lean initiatives for three international sites (one Unionized environment)

Evaluate production bottlenecks (VSM) and develop action plans to resolve

Conduct 5S and Kaizen events to reduce plant operating costs

Communicate metrics and project objectives, status, barriers, and results to all levels of the organization

Provide Lean training and consultation to more than 1000+ staff

Investigate problems to determine root cause and implement appropriate CAPAs

Project Highlights

Planned the construction of QA/QC, training room and storage facility including design of layout based on customized requirements of each department

Implemented new rewards and recognition programs that raise morale and provided continuous feedback

Quality Assurance Associate Investigations / Continuous Improvement

Teva Pharmaceuticals, Markham, ON 03/2011 – 05/2015

Perform comprehensive and detailed investigations specializing in complex quality deviations related to manufacturing process and analytical failures of finished product and stability studies (i.e. low yields, contamination, OOT/OOS results, SOP deviations, product recalls)

Lead multiple CI projects including DR cycle time reduction and Raw Material testing cycle time reduction

Personally accountable for >100 deviation and complaint investigations (including serious ADRs) annually with >99% on-time closure rate

Write and present Monthly and Quarterly trending reports (i.e. deviations, complaints, audits) including key findings and recommendations to senior management

Use statistical tools to support investigations including Quality Risk Management (i.e. trend analysis, histograms, linear regression, FMEA, FTA, HACCP, Cpk analysis)

Recommend appropriate CAPAs, issue Change Controls, write and revise respective SOPs/WIs

Perform routine quality system audits and issue non-compliance observations as required

Received overall Exceptional rating on performance evaluation

Quality Assurance Associate (co-op)

Experchem Laboratories Inc., Toronto, ON 08/2010 – 12/2010

Review of Batch Production Masters/Records for various clients and dosage forms

Review of Raw Material specs, Finished Product specs, CofAs and CofMs

Review of labels and masters for compliance to regulations (DIN, DIN-HM, NHP, MD)

Review and trending of stability data

Identifying and issuing deviations for non-compliance observations

Writing, editing, and proofing of SOPs and Change Control Reports

Initiating change controls for SOPs and Forms based on evolving needs

Quality Assurance Document Reviewer / Alternate Quality Person in Charge (A/QPIC)

Apotex, Richmond Hill, ON 05/2008 – 12/2009

Contribute to faster identification and turnover of quality issues thereby improving production cycle times, deviations per packaged lot and Right First Time metrics

Report, investigate, and follow-up on quality issues/deviations as they occur on-line

Review and approve POMs ensuring all critical parameters and yields are within specifications

Conduct laboratory tests for pH, density, viscosity, osmolality, specific gravity, and appearance to ensure bulk product conforms to CoA specs

Conduct Acceptable Quality Level checks and Non-conformance quality investigations

Lead meetings to communicate latest corporate news and metrics to quality department

PERSONAL PROJECTS

eldonkao.com, Toronto, ON 06/2015 - present

Author of a professional blog featuring Continuous Improvement/Six Sigma trends and advice

Attracts approximately 300+ unique visitors monthly

EDUCATION

2007 B.Sc. (Hons.), Biochemistry Co-op Program, University of Waterloo, Waterloo, ON

2010 OCGC, Regulatory Affairs and Quality Operations Co-op, Seneca College, Toronto, ON

2013 Certificate in Project Management, University of Toronto, Toronto, ON

PROFESSIONAL TRAINING

2011 CAPA, Academy of Applied Pharmaceutical Sciences, Toronto, ON

2013 Lean Six Sigma Yellow Belt, Teva in partnership with MoreSteam, Toronto, ON

CERTIFICATION

2013 Quality Improvement Associate (CQIA), ASQ License 10006

2016 Project Management Professional (PMP), PMI ID 4032374E1

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