• Coordination of the Quality Control team, including acting as an advisor for daily operations of the team, establishes priorities in line with the site objectives/timelines.• Organization, planning and support to the QC team members in any analytical/technical questions and problems, in order to ensure efficiency and accountability of the group.• Ensure that all activities, including equipment utilization, are in compliance with cGMP, regulatory guidelines and industry standards• Prepare, update and review SOP’s, protocols, investigations, CAPA’s, change controls and technical reports.• Evaluates/troubleshoots routine and non-routine technical/analytical problems along with assisting in specific investigations inside the laboratories and manufacturing.• Responsible for assisting and training lab personnel• Responsible for the management of laboratory testing data i.e. analyzing and interpreting data, data entry, validation of data and final approval/release.• Management of the Quality Control team projects, including assisting in performing validation of new laboratory instruments and testing methods.

• Responsible for the management of the sites adherence to the regulatory guidelines by ensuring the productions areas are all with in compliance.• Performing daily inspections/audits across all three shifts in packaging and manufacturing to identify and assist in the resolution of any GMP violations.• Performing internal audits of the quality systems.• Responsible for the creation of a QA inspection program site wide which will be designed to strengthen the sites compliance to all of the pharmaceutical regulations.• First responders to any potential quality event, responsible for triaging the situation and determining the next course of action.• Responsible for writing investigations (rRCI, CAPA), along with assisting investigators compile the correct documentation to complete investigations. • Provide a quality presence on the production floor, in order to mentor the operators and production staff on the proper GMP practices.

• Fully trained in Micro Limits Testing (MLT), Microbial Enumeration Testing (MET) and Environmental Monitoring Testing.• Support Research and Development group for MET/MLT testing and environmental microbiology• Trained in several different processes/equipment for organism identification in the laboratory (Vitek2, MIDI GC).• Data entry of laboratory results into LIMS along with updating and building testing standards.• Involvement writing in QA/QC investigations for OOS/OOE.• Involved in creation, updates, and execution of various laboratory documents (SOP’s, validation protocols, testing frequencies, construction/new equipment project plans).• Involvement in laboratory and production equipment qualifications and validations• Familiar with several Rapid Microbiology Testing methods (flow cytometry, fluorescent tagging)• Ability to use several types of lab equipment (GC, HPLC, ion chromatography).

• Responsible for granulating, milling and blending several types of drug product.• Responsible for properly cleaning and setting up the equipment needed for granulation, milling and blending.• Strictly adhering to all the necessary SOP’s and GMP guidelines