Jaclyn Brooks Email & Phone Number

Mississauga, On, Ca

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.• Supports regulatory submission activities, including coordinating and managing product launches asthey relate to quality compliance.• Conducts self inspections and audits for internal and external clients. Proficient at audit scheduling andaudit report writing.

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;•Collaborating with third party manufacturer Quality Assurance and Clorox R&D in the creation, review and approval of finished product specifications in compliance with Natural and Non-prescription Health Products Directorate (NNHPD);•Implementation of a stability program that meets compliance regulations to ensure the shelf life and storage conditions are as per approved specification;•Documenting and reviewing annual product quality review (APQR) to ensure the consistency of manufacturing processes and possible improvements to methods and processes. Product quality is evaluated via trending of deviations, customer/consumer complaints and change controls; •Managing the documentation and investigation of deviations, consumer/customer complaints and other non-compliance issues related to product quality. Implementation of corrective/preventative actions when identified as appropriate to eliminate non-conformities; •Overseeing the management of controlled documents via record retention policies;

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 service oriented manner and provide status reports;• 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 times, pricing and system guidelines;

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• Aseptic laboratory technique

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