Jaclyn Brooks Email & Phone Number

Mississauga, ON, CA

• Set up new clients seeking importation and distribution of drug product, medical devices and naturalhealth products in Canada.
• Ensured compliance to regulatory requirements through the development and implementation ofgoverning SOPs and Quality Agreements.
• Participates in and contributes to cross-functional teams to review and optimize projects from drugdevelopment to product launches in Canada.
• Manages multiple clients with multiple projects with varying priorities and timelines. Exceeded clientexpectations on deadlines, budgets and other deliverables.
• Liaised with external manufacturers to ensure compliance and favourable outcomes to the quality andmanufacturing systems such as change controls, deviation, complaints and root cause analysis forinvestigations.
• Continuously monitored the performance of the quality systems and assessed key performanceindicators as a mechanism to proactively propose continuous improvement initiatives or managequality improvement plans.

Toronto, Ontario, Canada

• Creation of internal quality audit program in compliance with Health Canada requirements. Execution and management of the internal quality audit program annually;
• Creation and implementation of a change control program;
• Creation and review of SOPs to ensure they are compliant with Health Canada requirements and adherence to SOPs through internal auditing programs;
• Review of executed batch records. Ensure all records are complete as per Good Documentation Practices (GDPs) and in compliance with Health Canada’s Good Manufacturing Practices (GMPs);
• Assurance that GMPs are upheld through the effective implementation and execution of local and global quality management systems (QMS);
• Sample inspection and review of product specification in order to meet Health Canada requirements for the release of finished goods (NHPs) including finished product testing;

Mississauga, Ontario

• Liaises with global manufacturing sites; requesting and coordinating required documents for release;
• Process improvements through innovation and overseeing project life cycle when implementing process improvements;
• Coordinates quality systems: returns, confirmatory testing and inspection plans in our SAP system;
• Participated in a Health Canada Audit;
• Performs and evaluates product for the purposes of product disposition of DINs, NHPs, Consumer Goods, Biologics and Medical Devices;
• Ensures that the Quality Assurance and Quality Control teams operate at the highest level ofcompliance and business efficiency and provides the necessary support from a compliance perspective to the business groups.

Mississauga, Ontario

• Key Account Representative; managed two of the three largest commercial accounts at Bayer (Loblaws and Shoppers Drug Mart) for Pharmaceutical and Consumer Health divisions;
• Enter customer orders into SAP system;
• Cross functional collaboration between Corporate Functions team including Supply Chain, Quality Assurance and Sales Team;
• Process customer complaints through the proper channels, provide solutions within scope of authority, and follow up with customer while maintaining GMP compliance;
• Verify shipments and deliveries, maintain quote information, provide answers to product knowledge questions, problem solve, assist management and assigned sales representatives and customers in a professional and.
• Ensure that variations in customer's expectation related to price, lead-time or specifications are communicated and agreed upon prior to order entry and sales orders are entered accurately, following appropriate lead.

Waterloo Ontario

• Passaging and feeding of cells grown in both adherent and suspension cultures including cell dissociation, counting cells and preparing new culture vessels for passaged cells.
• Resuspension of cells from cold storage
• Sterile media preparation
• Cryopreservation of cells
• Microscopic evaluation of confluence and morphology
• Cell counting and growth curve calculations

Waterloo, Ontario

• Subject area of focus Genetics and Cellular Functions
• Specializing in tutorial and lab sessions with Teaching Assistant for a class without supervision from the Professor
• Assisting the professor with various academic tasks such as marking assignments and grading papers
• Setting up and attending weekly meetings for other instructional assistants

Certificate, Project Management

Bachelor Of Science (Bsc), Biology, General

Activities and Societies: Vice President of Laurier Biology Student Association