Responsible for building and supervising a team of manufacturing specialists tasked with authoring change controls, investigations of root cause, deviations and CAPAs, and performing first level review of batch records / logbooks. Focus on driving efficient processes and first time quality.
Team formation o Build a team of technical operations specialists. Team will focus on coordination and receipt of information from multiple departments and ensure on-time lot release. o Staffing and training of employees within area of responsibility. Effective resource management using cross training and flexible creative approach o Develop and manage metric systems to monitor performance within area of responsibility Documentation Management o Responsible for driving efficient batch record, deviation, CAPA and change control closure via visual boards, daily operations meetings or other avenues. o Supervise technical operations specialists focused on tracking and facilitating closure of batch records, change controls and other documentation required for batch release. Investigations o As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations. o Prepares and analyzes manufacturing and historical data, and uses methodical root-cause analysis tools to determine root causes and effectively documents the root cause. o Properly assess the manufacturing or analytical environment and independently conceives and documents appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using analytical tools. o The individual in the position provides technical expertise to the site on thorough and complete deviation investigations.
Experience / Education:
Knowledge / Skills / Abilities:
Equal Opportunity Employer Minorities/Women/Veterans/Disabled