Tj Cooper Email & Phone Number

Brantford, On, Ca

Brantford, Ontario, Canada

Brantford, Ontario, Canada

- Managed the site’s stability program as the subject matter expert ensuring product safety and efficacy throughout the duration of the shelf-life in accordance with International Council for Harmonization (ICH) guidelines, while also compiling and analyzing historical data to introduce cost-saving measures and promote greater efficiency with in-house testing- Led customer complaint resolutions as the principal investigator by facilitating interdepartmental root cause analysis meetings using industry standard techniques such as Ishikawa diagrams, failure mode & effects analysis (FMEA) charts, the American Society for Quality's Five Whys System, and the Pareto principle, resulting in a ~68% reduction of complaints year-over-year- Served as project manager for corrective and preventative actions (CAPA) in response to Health Canada observations, and various continuous improvement endeavours through the change control process and plan-do-check-act (PDCA) cycle- Provided interpretation of Health Canada’s good manufacturing practices (GMP) guide for drug products (GUI-0001), as well as ISO 9001 and ISO 13485 quality management systems (QMS) to ensure ongoing compliance- Trended key quality indicators and created annual product quality reviews (APQR) for submission to regulatory bodies - Participated in documenting, investigating, and communicating deviations, out of specification (OOS) results, out of trend (OOT) results, nonconformance reports (NCR), and risk assessments- Worked in tandem with the site's QRA Director to facilitate and conduct both internal and external (Health Canada, MDSAP, customer, etc.) audits with successful results- Authored and revised standard operating procedures (SOP), protocols, and technical writing projects with a continuous improvement mindset and Lean Six Sigma concepts to increase efficiency and effectiveness of various manufacturing processes.

Ancaster, Ontario

• Ensure the highest standards of food quality and safety are met via the ongoing assay of raw materials, finished products, equipment, personnel, and facilities at the time of production, in addition to pre-operational inspections and the scientific analysis of goods post-production• Conduct thorough investigations to determine the root cause of customer complaints, draft and log detailed non-conformance reports in the event of a deviation from best practices, and work collaboratively with the associated departments to implement corrective and preventative actions to preclude future reoccurrences• Prepare for internal and external audits through daily documentation review and verification, as well as the facilitation of zone audit walk-throughs in order to consistently achieve the highest BRC grade of “AA”• Establish and maintain the microbiological assessment and pest control initiatives to monitor and rectify problematic trends with the potential to compromise the safety of finished goods• Manage the holds and batch releases of raw materials and finished goods via the positive release program• Develop programs and policies, as well as provide individual and group training to employees, covering topics such as SOPs, GMPs, food safety, HACCP procedures, SPCs and KPIs• Cooperate with the production and regulatory departments to verify the packaging and labelling of foods are in compliance with the standards of the governing bodies

Brantford, Ontario

• Spearheaded equipment reorganization and construction projects throughout the facility • Completed various inventory management, data entry, record keeping, and archiving tasks

Brantford, Ontario