Insightful Manager with nearly two decades of experience directing and improving quality and operations through effective employee motivational strategies, servant leadership, and process improvements. Proficient in best practices, industry trends and regulatory requirements of pharmaceutical operations. Talented leader with analytical approach to strategic business planning and day-to-day problem-solving.
Procedural Improvements - I was a key member in developing a new SOP system where over 180 SOPs and forms were revised as part of a regulatory inspection response. Subsequent to this response all applicable SOPs within the organization were updated to include better step by step instruction, pictures, and color coordination between procedure and form. This procedural change improved the digestibility of SOPs for people unfamiliar or new to the process, ultimately reducing the amount of "new employee" errors.
Sliders for the Vibratory Screeners - Reduced the number of vibratory screener cross-contamination investigations by 80% through the implementation of Vibratory Screener Sliders. I was the lead of the team for this project which included scheduling time with equipment and personnel, ensuring that the appropriate materials were tested, drafting all protocols, and acquiring the documentation for approved FDA materials of construction.
Safety Screens for Weighing/Dispensing - I identified the root cause of cross contamination within the Weighing/Dispensing department and implemented a safety screening process. As a result of this process there has been a 100% reduction in fibrous, paper, or bag contamination investigations. Prior to this project an average of 2 batches were impacted per month resulting in partial, if not full batch reduction.
Competitive Style Compliance Training - I developed, and led a competitive style training system which motivated personnel to study and improve their knowledge of their procedures. Operators drafted teams and competed against each other for company sponsored prizes in a bracketed system which resulted in a Quality "Grand Champion". This initiative drastically improved the level of detail that personnel were trained and raised the shop floor morale.
Employee Solution Submission box - A "Solution Box" was established on the manufacturing shop floor where employees could deposit Quality Solutions. Over the course of a 12 month period 18 solutions were submitted, and 14 approved. The concept of "Solution" over "Suggestion" empowered personnel to innovate quality ideas rather than simply identify issues. As a result of this project there were procedural, batch record, and process revisions made that improved cleaning, quality, and efficiency.
Equipment Cleaning - Reduced the number of failed equipment cleans by 92% by developing more effective cleaning techniques, identifying better cleaning tools, and improving the standard work forms. I was a key member of a CAPA for failed vibratory screeners where identified an engineering fix that has resulted in a 100% reduction in vibratory screener failed cleans. I implemented several cleaning and inspection tools which allowed the operators to improve their "right first time" cleans.
AQL Improvement Project - I developed a AQL inspection process that reduced the processing time by 80% while improving the efficacy of the inspection. The AQL program included standardization of time, tool, environment, employee training, employee eye exams, and level of light. This process improvement eliminated over 2000 hours of man hours each year and has been evaluated by multiple regulatory agencies and customers without comment or audit finding.
Event/Deviation Design - Due to the ineffective format of investigations, customers would reject or find comment with closed events or deviations at a rate of greater than 20%. This resulted in excessive delays in shipment or batch testing/processing. To correct this, I developed a template that incorporated all of the most common regulatory or customer comments/feedback into a standard template and established an SOP to support the processing of investigations. After the change comment/revision requests are now