Support the business in the transitional stages of adopting new enterprise systems including SAP-CAPA and SAP-SCC.Ensure operational compliance to site operating procedures, corporate conformance standards, regulatory guidelines and policies. Review and approval of all Manufacturing/Packaging Manufacturing Investigation Reports with implementation of process improvements.Optimize operations training approach with the Pharmaceutical Operator Training Curricula re-design.Optimized the operations Zone Management Program.Operations representative during FDA, Corporate MSQA, EH&S and Internal Audits. Responsible for timely response to inspection findings.

Direction of up to 17 direct reports within the QC Incoming Material Sampling Group, QC Incoming Material Testing Group and the Finished Product Testing Group.Completion and distribution of the Quality Control Operations Monthly Metrics Report and the Annual Laboratory Master Plan to the Senior Director of Quality Operations. Implementation of novel Lean Laboratory concepts including Visual Management, Role Cards and optimized testing efficiencies with Workcell Designs. Member of the Corporate Lean Laboratory Design Concept Team. The team was a recipient of the 2008 President’s Achieving Excellence Award. Development of the Quality Control Operations Safety/cGMP/6S Assessment Team, including integration of the site BASE (Behavior Awareness of Safety & Environment) Program.

Distributing work assignments and ensuring on time completion of the required tests according to cGMPs for all pharmaceutical/consumer healthcare incoming materials and finished products at the plant site. Including support of the stability testing program and the process validation testing program. Conducting timely investigations on all out of specification data, tracking and trending of known laboratory errors and commitments and ensuring effective CAPA..Providing technical training and familiarization with SOPs, cGMPs and General Methods to promote the highest level of performance by the staff of the laboratory and sampling group. Reviewing and approving all SOPs, monographs, validation protocols, analyst training curricula, change controls and technical transfer protocols. Serve as a vital role in the overall functioning of the business by serving as a liaison between the control chemists, manufacturing and quality assurance.Supported the business in the transitional stages of adopting new enterprise systems including GxPharma, Trackwise and Labware LACES/LIMS.Department representative during FDA, Corporate GCA, and Internal Audits. Responsible for timely response to inspection findings.

Chemist responsible for performing general wet chemical techniques. Experience in instrumentation includes HPLC, GC, AA, ICP, NIR and FTIR. Familiar with cGMP and USP regulations/procedures.Responsible for maintaining and generating SOP documents; including optimization of the Laboratory Standard & Reagent Maintenance Program. Representative for departmental safety and cGMP committee.

Research assistant in the synthesis of several novel compounds. Tasks included organic synthesis, characterization of compounds through the use of mass spectrometry and NMR..