Contact Information

T: 905.363.1182 x.233
F: 905.542.7981

TF: 1.877.877.5152 x.233
M: 647.401.4351

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Lead Consultant

Meagan Boucher is a capable quality assurance professional. She has experience in corporate and third party audits, root cause analysis, and corrective actions. She is able to manage multiple projects while meeting required deadlines. She is also skilled at developing Quality Standards and Standard Operating Procedures.

Skills & Highlights, Big Project

Quality Control (QCO)/Quality Assurance

  • Participated in Audits and Investigations with Third Party Auditors
  • Participated in conducting audits of third party facilities
  • Responsible for reviewing, investigating, analyzing root cause and participating in corrective actions for consumer, customer, sales and plant related complaints
  • Conducted studies, collected downstream samples, ran tests, collected data, to determine route cause and prepare reports and summaries to display results
  • Implemented system to provide control of third party suppliers, ensuring they understand and meet or exceed Quality Standards
  • Compiled and reviewed Annual Product Quality Reviews
  • Responsible for review of batch documents and product batch release for imported and contract manufactured products
  • Performed data integrity reviews for laboratory data
  • Reviewed and approved master production and stability documents and protocols
  • Performed review of deviations, change controls, CAPAs, and master packaging and manufacturing documents
  • Prepared deviations for third party packagers

Validation

  • Developed cleaning validation for manufacturing equipment
  • Developed process validation test scripts for products and laboratory equipment 
  • Prepared and executed temperature mapping protocols for various product storage areas, and equipment
  • Prepared temperature mapping validation risk assessments

Technical Writing

  • Developed Quality Standards and Standard Operating Procedures
  • Lead the documentation process and tracking of quality projects and goals, and support all corporate trials of new products
  • Reported deviations 
  • Documented assessments of risk and impact to product quality

Computer Skills

  • Trackwise, Deviations, CAPAs, Change Control

Education

  • McMaster University, Bachelor of Engineering, Chemical Engineering, Hamilton ON

Continuing Education, Career Development

  • Audit skills course, Q&C
  • Technical writing course, Q&C
  • USP–NF General Chapter 1231 – Microbial Control of Pharmaceutical Water Systems
  • Working Smart, Microsoft Outlook, Progressive Training