Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

47

 Prioritizes and coordinates laboratory schedules and projects in order to facilitate completion and meet department and corporate goals.  Investigates non-compliance situations in order to determine cause and initiate corrective action.  Helps resolve problematic laboratory testing and makes recommendations to external departments for corrective action.  Ensures that stability data and trends continue to meet specifications and to support the established / tentative expiry dates for products.  Evaluates stability data and performs statistical analysis as needed, and formulates conclusions for stability reports of products enrolled in the program.  Develops and implements statistical tools for ongoing trend monitoring and evaluation of stability data interpretation, documentation and review.  Initiates Out Of Specification events for failed stability samples and investigates the root causes and impacts of the failures.  Develops, reviews, revises, or approves Standard Operating Procedures (SOP's) as required.  Develops training materials on new or revised SOP's and participates in training to ensure that staff adheres to those procedures accordingly.  Perform Root Cause Analysis, working with both R&D and Technical Operations when stability issues are found and develop an action plan for successful resolution. Stability Program, Manager Pharmavite LLC December 2013 - January 2014  Develop a centralized global Stability Program specific to Dietary Supplement  Updates stability regression charts for current stability studies and reports on study trends.  Reports on products with potential expiration dating issues to management.  Monitors and maintains conditions of stability chambers and storage locations. R&D Analytical. Supervisor Pharmavite LLC July 2010 -December 2013  Supervises, trains, and develops staff. Responsibilities include interviewing, recommend hiring and training employees; planning, assigning, and directing work.  Assist in reviewing stability data. Reviews stability data and recommends course of action to address negative trends observed in the data.  Investigates all assay results which are outside of expected norms to ensure proper analytical techniques and practices were performed by chemists and temps.  Leads and develops department staff to maximize productivity and to maintain high team morale. Promotes a positive culture and capable of team building to ensure employees will work well together to increase efficiency and productivity.  Supervises and develops chemists and temps to ensure that R&D assay demands are met in a timely and accurate manner.  Conducts analytical testing and resolves analytical issues.

08/09/2018