Colin Froese Email & Phone Number

Steinbach, Manitoba, Canada

• Managed site Quality Change Control and Controlled Document programs ensuring timelines and business needs were met while ensuring compliance to industry regulations. Participated in site audits from regulators and.
• Led and implemented improvements to site processes, across multiple departments, by challenging current practices through involvement in LEAN and Operational Excellence programs.
• Managed identification, collection and transfer of all Quality documents to new organization when company split into two entities.
• Led multi-departmental team in selection of an electronic document management system, from identification of user requirements to final vendor selection.

• Managed multi-departmental teams and timelines directed towards the transfer of new manufacturing and testing processes into the site. Prepared and balanced project budgets throughout the life of the project, including.
• Challenged and promoted new opportunities for improvements to legacy manufacturing processes to reduce manufacturing costs.
• Presented information and training about new processes and procedures to both plant and smaller working groups and ensured information was disseminated accurately to limit procedural errors.
• Collaborated as a key Controlled Substance Team member with a multi-departmental team to successfully increase the sites rating and meet business needs.

• Re-developed the Stability Program and optimized use of key team members resulting in the elimination of 100+ outstanding reports and allowed for ability to take on additional technical reports including the APQR and.
• Saved $50,000 through the optimization of the Stability chambers enabling the accommodation of 40-50% more inventory.
• Developed and implemented the Controlled Substance Program resulting in the first controlled substance license on site.
• Reduced laboratory costs by >$40,000 annually by reducing Stability testing and sample selection.
• Developed a system for trending Stability Results which included a central site database that eliminated excessive duplication of work across the site. Supported site investigations through the uses of statistical.
• Participated in successful internal, external and regulatory inspections/audits.

• Supervised day-to-day operations in the laboratory ensuring testing was completed within required time frames. Simultaneously led investigations into irregular test results, trained new analysts, and.
• Developed a laboratory sample metrics tracking system to determine departmental status, and meet testing due dates and site performance goals.
• Through planning, critical thinking and team leadership successfully led the dissolution group to complete 100% of testing on-time in 2004 and increased efficiencies in 2005 by 40%.
• Improved documentation practices by developing a reporting template for lab investigations. Guaranteed consistency and accuracy of all laboratory investigations and implemented use of system logbooks to ensure.

• Tested analytical samples to ensure products met all regulatory requirements using various analytical instrumentation including; Karl Fisher, FTIR, Polarimeters, Refractometers, Viscometers, Laser Particle Size.
• Performed environmental testing within the facility to ensure air and water systems met regulatory requirements.
• Conducted instrumentation validation and method development of laboratory equipment including the creation of standard operating procedures, test methods and other validation documentation to ensure equipment and.