Jennifer is a committed, self-motivated and flexible individual with strong organizational and problem solving skills. With extensive experience in quality assurance and quality control for GMP and ISO systems, she provides valuable depth to the Q&C team. She manages her time effectively, and can work well as a team member or independently. Jennifer is able to establish and meet timelines for activities, managing and executing multiple tasks quickly and efficiently with minimal supervision.

Quality Control Officer (QCO)

• Performed product release and QCO services for GMP-compliant customers.
• Assisted in release of finished products, drug products, clinical supplies, raw materials, and packaging materials.
• Released components and finished products for medical device manufacturer.

• Developed and maintained specifications (Packaging Materials, Raw Materials, Drug Product, Clinical, Bulk, In-process, Finished Product, Stability) and QA/QC test methods.
• Reviewed manufacturing and packaging documentation.
• Managed complaint investigation system.
• Managed non-conformance and change control programs.
• Prepared annual product reviews.
• Investigated GMP deviations and implemented corrective and/or preventive actions.
• Organized QA department for FDA inspection for Canadian medical device manufacturer.

• Performed impact review of regulatory updates.

• Performed internal audits to ensure compliance with corporate quality standards.

• Performed employee training on standard operating procedures (SOPs).

• Developed and updated policies, GMP SOPs, and ISO quality system procedures to meet FDA and HPFBI requirements.

• Reviewed validation documentation.
• Supported all aspects of in-house validation activity and at contractor sites for Canadian pharmaceutical manufacturer.

• Worked as an animal/research technician and process/product development technician for a Canadian medical device manufacturer.

• Honours Bachelor of Science, Biological Science, University of Guelph, Guelph, Ontario

• Annual Product Review, PSG
• Audit Skills
• cGMP Annual Product Reviews
• Change Control Management, IPA
• Conducting GMP & Compliance Quality Audits
• Controlled Drugs and Substances, PSG
• Deviations and Change Control
• Fundamentals of Regulatory Affairs, CanReg
• GMP Fundamentals, PSG
• GMP Overview
• GMP Training Program, KMI/Parexel Inc.
• GMP Training Update, CanReg
• GMP/GLP Training
• Introduction to Regulatory Affairs, PSG
• Management & Leadership Skills for First-Time Supervisors & Managers
• MS Access® Training
• NHP Regulations, Q&C
• Product Disposition, Q&C
• System Validation and Introduction to 21 CFR Part 11, Invensys
• Technical Writing Course, Q&C
• The Compliance Conference, Insight Compliance Training Group
• WHMIS certification
• Women's Leadership Conference, Rockhurst University CEC, Inc.