Derek Johnson Email & Phone Number

Denver, Co, Us

Fort Collins, Colorado, United States

Highly proficient Second shift QC Supervisor directing teams of analysts at two separate manufacturing sites. I coordinate with fellow members of management and testing analysts to ensure QC operations meet company policy, on time delivery, quality, safety, and compliance requirements. I lead teams performing in-process, release, and stability testing of cancer treatment and dermatology drugs. I also perform investigations, certificates of analysis, lean initiatives, audit preparation, management of testing schedules to maintain adherence, and performance management.

Hamilton, Montana, United States

In this role I focused on reducing testing turnaround time and QC cost for monitoring, in process, and commercial QC release utilizing lean production and continuous improvement principles. A priority was always having QC operations prepared and versatile. A significant portion of this work was creating, planning, and performing activities by standardized schedules. This had the intended effect as testing productivity and capacity were increased, and waste reduced. I led and was a team member to help achieve the goals of increasing the amount of value stream product made and met two production facility expansions. I influenced and motivated two distinct departmental teams to process change and meet QC and site priorities. I deeply valued being appointed and serving as a critical member on site cross-functional teams for deviations, internal and regulatory audits including FDA and EMEA, contract lab event investigations, process improvements, and achieving company milestones.

Hamilton, Montana, United States

As an important team member I performed SOP revisions and reviews, OOS/OOT and deviation investigations, CAPAs, change control, validation (methods and equipment IQ/OQ/PQ), analytical chemistry including wet chemistry and HPLC, EM/UM, microbiological and in-vitro and in-vivo biological assays accomplishing for “right the first time” work. Keys to success were reinforcement of all policies and procedures, full support of management decisions and goals in a professional manner, and to demonstrate awareness of changing schedules, requests, and priorities put forth by management. I served as a primary data reviewer and approved the release of manufacturing processes and product batches in accordance with corporate, regulatory, and external regulations. I worked with the QC Supervisor to mitigate safety concerns, technical and compliance issues: to set, monitor, and achieve area objectives, metrics and targets. (Note: March 1992 to May 2007 and August 2010 to September 2014).

Hamilton, Montana, United States

I supervised one of two QC analytical shift teams and planned and coordinated support for commercial products in compliance with GMP, company standards and regulatory agencies. A critical component was to ensure the required verbal and written information were always compiled and transferred on time with the right quality to our and the opposing shift for consistent, continual operations. I oversaw systematic data review, approval, and quality decisions in daily operations. Personnel development and execution improvement by mentoring, coaching, technical training, and performance reviews helped analytical QC achieve an increase in analyst method training while decreasing the invalid test results rate. I gained a substantial understanding and use of QMS resulting in QC consistently meeting customer requirements. I learned to prioritize tasks, determine course of actions, and implement effective decisions. I had the knowledge to be answerable to QC analytical operations, identified the talents of personnel, and encouraged direct reports to meet their potential.

Bachelor Of Arts - Ba, Cell/Cellular And Molecular Biology

Minor, Chemistry