Dawn Visintainer Email & Phone Number

Salmon Arm, British Columbia, Ca

• Collaborates directly with the owner on business strategy.• Leads the development, communication, and implementation of effective operational strategies and processes by setting comprehensive and clear key performance indicators to measure effectiveness of all operational processes that support the company’s strategic plans.• Manages Growth and Operational personnel, including, sales, marketing, production, supply chain, quality, regulatory, security, and health and safety. • Acts as the RP and QAP for the site and license holder, ensuring compliance to all applicable regulations. • Develops departmental budgets and product cost structure and identify cost improvement opportunities. Review and approve departmental expenses and capital budget.

Kelowna, British Columbia, Ca

• Execute strategic quality direction for new business, new products, and process improvements.• Work closely with executive management to provide quality assessments regarding compliance, gap analysis, corrective actions, contract provisions, accreditation standards, and internal policies and procedures.• Monitor external regulatory developments and the impact on the internal quality systems.• Assess risk from products, suppliers, processes, and optimization prior to implementation into ​the QMS.• Develop and integrate quality systems for new processes and optimized processes.• Develop and integrate a stability program.• Plan, direct and oversee the operations and fiscal health of both the Quality Compliance and Validation departments.• Safeguard operational success through vendor, equipment and process validation, qualification and auditing programs.• Communicate and educate affected business areas about changes and support the modifications and implementation of operations, policies and procedures to ensure compliance.• Establish standards and guidelines for vendors, monitoring vendors to ensure these policies are being followed through quality agreements and/or technical agreements. • Develop and lead external audits of vendors, partners, and service providers.• Establish standards and guidelines for investigating customer complaints. • Improve value to customers by understanding needs and investigating root-cause of defects and implementing CAPAs.• Protect quality and efficacy of products through risk assessments by development and implementation of the Preventive Control Plan, through cleaning and process validations and through vendor and material assessments. • Lead Validation team in the development of ways to measure instrument performance, temperature mapping, and cleaning validation.• Track and trend issues, process control points, and KPIs for both the Compliance and Validation departments and take measures to eliminate deviation.

Kelowna, British Columbia, Ca

• Designed, implemented, and managed the Quality Management System at Valens that led to obtaining Health Canada licensing.• Established vision for Quality at Valens and drove quality initiatives across all aspects of the organization.• Promoted overall quality goals and achievements across the company and educated team members on quality principles.• Contributed to Production, HR, Marketing, Customer Services and Security activities during Valens startup; including, developing company policies, reviewing materials, and strategic planning.• Ensured efficiency of the QMS for all cultivation, harvest, extraction, CPG, packaging, labeling and shipping activities in the rapidly changing climate of the Cannabis industry.• Stayed current with ongoing changes in GMP regulations, Health Canada initiatives and other industry policies that could affect the company. • Managed internal and external audits for Health Canada, GMP, ISO and QA. Including addressing issues, preparing response reports, regulatory submissions and ensuring observations are addressed and closed within a reasonable time frame.• Responsible for training of all employees on applicable SOPs and GMP related topics; as well as, hiring and management of the QA team.• Worked with operations and cultivation to ensure integrity of live and dried plant population, as well as, oil products at Valens.• Defined overall testing strategy and test processes for new and existing product lines.• Worked with internal teams to conduct risk based analysis, address issues and deviations, conduct root-cause investigations, CAPAs, and ensure timely closure of issues.• Reported regulatory issues and concerns with the potential to impact product quality to executive management.• When applicable, contacted manufacturers and customers to ensure regulatory requirements were met. Ensured that all communications, results and outcomes were documented appropriately.

Kelowna, British Columbia, Ca

• Monitored turnaround time, established analysis schedules, planned resources, prioritized staff and instruments as necessary to ensure deadlines and customer expectations were met. • Participated in developing long range performance plans, milestones, goals and objectives. • Identified and implemented innovative, disciplined, and continuously improving business processes and systems for administrative and laboratory teams.• Planned and executed method development and modification projects.• Monitored and maintained quality systems by ensuring that required quality control measures are consistently adhered to and documented.• Responsible for all transactions involving narcotic, controlled, and /or restricted drugs, including receiving and shipping, inventory, record maintenance, manage licences and reporting to Health Canada. • Established strong familiarity with LIMS as it pertains to laboratory operations and reporting.• Participated/performed internal and external audits – ISO 17025.• Led, developed, coached, mentored, and evaluated scientific staff.• Ensured that employees were following SOP’s and worked to reduce non-conformances.• Provided information, instructions, and assistance to all staff regarding health and safety.• Handled performance and attendance management issues.• Promoted a zero-tolerance policy for non-compliance with the Office of Controlled Substances regulations.

Kelowna, British Columbia, Ca

• Instrumental in successfully obtaining Health Canada Analytical Testing License for Cannabis and ISO 17025 Accreditation.• Developed and implemented Quality Assurance and Control protocols in compliance with Health Canada and ISO 17025 standards.• Developed and validated new testing procedures and the verification of existing methods in accordance with ISO 17025 standards and various pharmacopoeias; including, pesticides, potency, terpenes, heavy metals and mycotoxins by GC-MSMS, UHPLC or ICP-MS.

Kelowna, British Columbia, Ca

• Played an essential role in obtaining ISO 17025 accreditation for analysis of PCB, Dioxins and Furans in Fish and Krill oil.• Developed and validated new testing procedures and the verification of existing methods in accordance with ISO 17025 standards and various pharmacopoeias; including, analysis of PCB, Dioxins and Furans in Fish and Krill oil by GC-MSMS; Environment Canada Reference Method for Analysis of PCBs, EPA Method 1316B, and EPA Method 1668. • Developed and validated new testing procedures for the analysis of pesticides residue in a variety of matrices by USP 561 and EN QuEChERS. • Developed and validated new testing procedures for the analysis of wine and berries for detection of volatile phenol's for profile determination, smoke taint and Brettanomyces detection.• Designed project specific analytical testing parameters and protocols and executed client dictated experiments.

Toronto, Ontario, Ca

• Ensured manufacturing and testing was done in accordance to appropriate standards for various industries; such as, pharmaceutical, cosmetic, beverage, and natural health products. • Ensured the quality of manufacturing in accordance to ISO 9001, GMP standards, and regulatory guidelines.• Reviewed and verified critical process steps on the Production floor and documented on batch records, equipment logs and other controlled documents.• Contributed to any investigations and deviations associated with the product under review.• Assisted the Quality Manager in providing guidance and direction to all operational departments to ensure good quality practices.• Ensured integrity of testing methods and data in accordance to GLP and pharmacopoeial standards.• Performed quality testing (GC, FTIR, UV-Vis, coulometer, volumetric titrator ect.) on raw materials, in-process goods, and finished products.• Participated in the development and validation of QC testing procedures.• Released or rejected goods according to specifications through analysis of analytical testing and batch review.

Vancouver, British Columbia, Ca

• Assisted in the setup of the first Enology laboratory at UBC Okanagan; including, curriculum for Enology courses.• Sampled, extracted, and analyzed (titration, UV-Vis, various assays, UHPLC-QTOF-MS) specialized metabolites. • Developed extraction methods for specialized metabolites. • Interpreted research findings, prepared written and oral reports. • Hired and trained technical staff and students.• Maintained laboratory supply inventories.• Organized hazardous waste storage and pick-up.

Vancouver, British Columbia, Ca

• Developed course curriculum and taught lecture and laboratory classes.• Prepared, set-up, and conducted labs involving: cell cultures, immunostaining, flow cytometry, ELISA, protein separation by gel filtration, gene and DNA regulation. As well as, bench chemistry, anatomy and physiology, microbial influence, and aseptic techniques. • Marked laboratory and lecture assignments and exams.

Vancouver, British Columbia, Ca

• Contributed to a research study designed to determine the health effects of specialized metabolites in humans as a cure/preventative measure for neurodegenerative diseases, such as, Alzheimer's and Parkinson's. • Conducted in field sampling, as well as, extracted and analyzed, by HPLC, specialized metabolites.• Optimized extraction methods and specimen handling of specialized metabolites.

Master Of Science (Msc), Biochemistry

Bachelor Of Science (Bsc), Microbiology