Charlette is a highly motivated, punctual and hard-working individual with strong communication and interpersonal skills, and excellent time management and organizational skills. With her work experience in quality control, particularly related to product release and its associated activities, and quality assurance, she is a valuable addition to our team and an asset on any project.

Quality Control Officer (QCO) Services

• Performed product release activities
• Reviewed finished product, raw material and stability specifications against compendial monographs
• Reviewed master labels against Health Canada’s guidelines
• Reviewed stability protocols against ICH and Health Canada’s guidelines
• Reviewed certificate of manufacture and analysis against finished product specifications
• Reviewed stability summaries against pre-established stability specifications and protocols
• Initiated, executed, and monitored change controls
• Investigated and communicated with clients regarding various deviations, including:
• out-of-specification results
• sample label deviations
• document deviations including master production documents, batch production documents, certificate of manufacture and analysis

Quality Assurance/Quality Control

• Participated in internal audits:
• Reviewed and updated company policies and manuals
• Interviewed employees in various departments
• Participated in meetings regarding the progress of current audits and the follow-ups from past audits
• As a member of a consumer complaints team:
• Composed monthly complaints report and prioritized problems of statistical importance
• Determined the source of the problems and established solutions accordingly
• Performed physical and functional tests on all packaging components in compliance to GMP, SOP, and GLP
• Documented coherent records in accordance to SOP and GMP
• Worked with various analytical instruments
• Maintained and updated computer system SAP on a regular basis

Education

• Bachelor of Science Honours Biochemistry/ Biotechnology Specialization (Co-op), University of Waterloo
• Pharmaceutical Regulatory Affairs and Quality Operations (Co-op), Seneca College