Kieran Clarke, BSc., C. Chem

Experience

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  Agriculture and Agri-Food Canada

  May 2006 - Sept 2006

  Research Assistant Co-Op

  Government food research facility, specifically dealing with local crop fruits and vegetables· Performed DNA analyses on microbial samples using PCR · Plated and observed fungal and bacterial growths· Maintained a clean and sterile lab area as per aseptic technique· Marked, measured and input growth measurements and observations· Prepared an end of contract report for supervisors on the findings of the research thus far· Prepared various media

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  Ingredion Incorporated

  Jun 2009 - Jul 2010

  Chemical Technician

  ISO 9001 accredited High Fructose Corn Syrup processing facility; QA/QC laboratory-Created method documentation for dry product testing to update procedural information-Trained incoming Plant Chemist on all samples collected and methods of analysis for laboratory-Microbial- sampling, media and plate preparation, inoculations, growth analysis and basic identifications for line sterility and pathogens-Equipment calibration and use with HPLC, UV-Vis spectrophotometer, manual titrations, turbidity and microscopes-Sampling and testing of incoming feed (corn), inline product, final product and wastewater environmental analysis -Sensory panel testing for taste and texture of final products Show less

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  Vale

  Jul 2010 - Oct 2019

  ISO 17025 accredited precious metals refinery; QA/QC laboratory, processing and analyzing mined materials-Promoted from Junior to Senior Lab Analyst in 2015 for showing an ability to learn and excel at a variety of stations-Developed a new method, including writing the procedure and procuring the supplies, of sample introduction for gas analysis of powder products-Trained 6 of 13 co-workers on various new procedures, including 3 new hires -Training new hires involves three months of direct supervision during shift work-Equipment repairs, maintenance, and use with ICP-OES, Gas Combustion analyzer, Gas Fusion analyzer -TOC analyzer, automated titrations, UV-Vis spectrophotometer-Performed a variety of general lab task such as: receiving, processing through wet chemistry and analyzing samples with minimal supervision, maintaining lab inventory-Audited the workplace as part of a Health and Safety committee; charged with raising, reviewing and assigning corrections for safety concerns including MOC reviews and preparing action plans Show less

  • Senior Lab Analyst

    Jan 2014 - Oct 2019

  • Junior Lab Analyst

    Jul 2010 - Jan 2014
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  Aleafia Health

  Feb 2020 - Dec 2021

  - GPP facility- Supervise and direct staff in the Quality Control Lab- Provide leadership and expertise in identifying and troubleshooting problems as they arise- Develop and implement new initiatives to improve workflow and improve efficiency while maintaining a high quality standard- Schedule, plan and arrange daily tasks and special projects to align with product/project deadlines by ensuring adequate staffing for each initiative- Motivate staff to foster a culture of teamwork and accountability through coaching and the setting of clear expectations/goals for them- Review staff performance and apply coaching when necessary- Coordinate with all departments to facilitate meeting aggressive product release deadlines- Creation and revision of all laboratory and Quality Control related documentation, including Certificates of Analysis, Product Specifications, SOPS, Change Controls, Deviation Reports, and OOS Investigations- Leading new product development from an analytical standpoint:- Development of new preparation and sample analysis procedures- Method design and Validation- Direct liaison between the Quality Control department and all other departments- Building and maintaining strong relationships with external vendors such as contract labs and instrumentation service companies- Lead discussions as a subject matter expert in laboratory procedure and testing considerations, including during audits- Training and coaching of staff to a high level of competence and ethical transparency- Responsible for assuring laboratory, its staff and procedures employed within comply with occupational health and safety guidelines (ie. OSHA)- Interpreting and applying various forms of regulatory knowledge (ie. GMP, GPP, GLP, Cannabis Act, ICH) and compendial methods (USP, EP) to support all aspects of the business- Performing any and every test and sample preparation procedure utilized in the Quality Control Lab when required to support staff Show less • Design and execute protocols for method development and provide technical advising to assist in new product development.• Initiate and follow through with actions required to close Change Controls, CAPAs, deviations, OOS investigations.• Documentation writing for SOPs, Change Controls, Deviations, OOS investigations, R&D studies, Validation reports, Product Specifications, and CoA development.• Training and leading new and current QC staff on the application of procedures and requirements, both operational and regulatory.• Fostering good relationships with suppliers, service providers and external labs through strong communication.• Writing and presenting reports on various investigations, research requests, and R&D studies.• Involved in audits, development meetings, and operational efficacy meetings to further business and operational goals though quality control departmental support.• Recognizing and applying various regulatory considerations (GMP, GPP, GDP, GLP, Cannabis Act, ICH)• Recognizing and applying various compendial methods and specifications (USP, EP).• Recognize OOS or OOT results and executes lab investigations.• Review data and complete written reports and certificates of analysis.• Test various forms of cannabis by chemical, microbiological and physical techniques.• Inspect incoming raw materials and finished goods.• Document test results and perform data entry, trending, and analysis of new and historical test data. Show less

  • Quality Control Lead

    May 2021 - Dec 2021

  • Quality Control Analyst

    Feb 2020 - May 2021
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  Food Safety Net Services

  Jan 2022 - Jul 2024

  -ISO 17025 Accredited Food Microbiological Testing Laboratory-Supervise laboratory operations to ensure compliance with Safety, the Quality System, Accreditation, and meeting Client Needs-Performing audits, inspections, and investigations-Initiation, tracking, investigation and completion of CAPAs-Participate and facilitate external audits on the facility-Perform internal audits of processes and ensure accurate performance and interpretation of test results,-Facilitate external audits of laboratory; both regulatory and client-Responsible for laboratory financials, budget planning, and achieving financial targets-Supervise training of new and current laboratory personnel in procedures and protocols-Administer laboratory personnel reviews-Meet with clients and directly address their needs as required and in collaboration with the Management Team.-Oversee status of all results and reporting to clients on laboratory results as needed (including notification of “out of specification” results)-Ensure and manage adequate staffing of the laboratory to balance workflow, including setting schedules-Prioritization and scheduling of samples, goals, and plans to facilitate accurate and timely results for clients while balancing with a growth mindset and a focus on developing and improving all systems throughout the laboratory -Building and executing detailed career plans for the development of staff with an eye towards the needs of the laboratory and the needs of the individuals for growth-Responsible for the safety of oneself and others Show less

  • Operations Manager

    Oct 2022 - Jul 2024

  • Laboratory Supervisor

    Jan 2022 - Oct 2022
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  Labstat International Inc.

  Jul 2024 - now

  Manager of Product Management

  Lead and manage the product management team, responsible for management of nicotine/tobacco and cannabis/hemp containing products and devices from distribution until destruction•Liasing with landlords, local authorities such as City Planning, Hydro, Fire, and Police Departments on facility related isssues•Direct the day-to-day activities of the laboratory staff and ensure all activities are performed in accordance and in compliance with Labstat’s Code of Ethics, Quality System, and Health & Safety policiesProvide operational, technical, and administrative leadership through management, planning and allocation of resources in order to achieve the laboratory objectivesConsistently produce accurate results focusing on both test results and time consideration/expectations. Ensure all results consistently stand up to internal and external audit standards and criteriaAct as the point of escalation for complex problems, both of a technical and non-technical nature, assisting in the assessment of root cause and the resolution of problemsDevelop ongoing business analyses which include; recommending, implementing and maintaining practices and processes to continuously increase productivity and efficiencyEnsure execution of GLP and ISO 17025 requirements with regard to operations and documentation requirementsParticipate in internal and external audits and inspectionsLead continuous improvement activities with the Product Management teamWorking with Operations peers and schedulers to ensure availability of resources and equipment to maximize utilization and throughput.Lead and inspire a culture of safety firstImplement the Laboratory Quality Policy and perform their duties in accordance with existing project specific requirements, study plans, current Test Methods and Standard Operating ProceduresWork with Product Management Office (PMO) to track and update E29B’s. Liaison with Canada Border Services Agency for destruction and E29B acquittal. Show less