● Manage metrology program at QC, RM, R&D laboratories Utilizing LIMS LabWare system. Creates Calibration and Qualification procedures (SOPs /Protocols) for laboratory instrumentation via Master Control software● Reviews calibration documentation generated during the calibrations performed by other Meterologists and Vendors.● Maintain and update calibration LIMS (Labware 6.0) critical data ● Manage and maintains calibration data generated by the Instrumentation Department and Vendors● Participates in training of analyst on existing and new laboratory instrumentation.● Assigns work for meteorologist and vendors.● Create Change Controls and Investigations Via TrackWise ● Create Change Controls, OOS Investigations and CAPAs utilizing TrackWise system.

Responsible for daily operations of QC Laboratories Support Group/Metrology, which include Instrument Repair, Calibration, Maintenance, Qualification, Standard Operating Procedures, and Laboratory Investigations.Manage and Coordinate Vendor’s contracts and activities for all laboratory instrumentation services to ensure timely service, maintenance, calibration, qualification (IQ, OQ, PQ/PV) of all laboratory instrumentation.Assure timely calibration, qualification, preventive maintenance, and repair of laboratory equipment.Review in-house/vendor’s IQ/OQ/PQ protocols to ensure compliance of vendor protocols and documentation with company policies, relevant SOPs and regulatory and compendia requirements.Generate, review, and approve qualification and validation protocols, SOP of maintenance, calibration, and validation of equipment.Provide training to laboratory analyst on instrumentation, safety, troubleshooting, software and hardware of instrumentation (Empower, Chemstation, and other vendors software) Conduct investigations of OOS, OOT and Aberrant laboratory test results, calibration failures, and determine the appropriateness of corrective actions.Overlooking all aspects of laboratory readiness of new contract products:- Instrumentation purchase and readiness - Purchase of needed equipment and instrumentation- Create necessary qualification protocols, operation, maintenance, and calibration SOPs.- Oversee method transfer for new product contractsCoordinate activities with vendors for service, calibration, qualification, and validation activities.

Supervisor - January, 2005 – April 2009 PLIVA/ BARR PharmaceuticalsResponsible for managing all metrology activities pertaining to Quality Control equipment used at PLIVA, Inc./Barr Labs in East Hanover to support current marketed product in both the US and EU. Design and create Standard Operating Procedures for all laboratory instrumentation Design instrument qualification (IQ/OQ/PQ) and calibration protocols as per current industry requirements.Repair, maintain, calibrate, and qualify most laboratory instrumentation including HPLC, GC, UV, Dissolution, and more.Coordinate activities of administrative and laboratory staff supporting calibration, preventive maintenance, and repair activities. Manage and coordinate activities performed by outside vendor service providers. Train / lead / develop the group based on the current business requirements. Work with QC and QA management and come out with resolutions for issues related to metrology and laboratory investigations. Work closely with QC Stability and have a good understanding of the stability program and requirements within the company.Initiate investigations related to OOS, aberrant or OOT calibration and laboratory test data. Assess results and write conclusive reports on the disposition of the instruments. Ensure all work is performed in accordance with cGMPs, USP, and PLIVA, INC. /Barr Labs, standard operating procedures. Train / supervise/ develop the metrology group and laboratory personnel based on the current business requirements. Assesses/conducts performance reviews on all direct reporting staff as well as jointly held supportive staff.

Novartis Pharmaceutical October 2001 to January 2005Supervisor. Analytical QC•Supervised eight Instrumentation scientists. Key job responsibilities include assigning work and allocating resources with regard to lead-time and schedules.•Scheduled monthly calibration assignment using Calibration Manager Software from Blue Mountain Quality Resources.•Managed calibration, qualification, preventive maintenance, and repair program for all QC laboratories in Suffern NY.•Ensured adherence to the federal (FDA, DEA), OSHA safety regulations, GMPs. Preparation and processing capital appropriation requests.•Designed needed SOPs, Calibration Procedures, and Qualification Protocols. Responsible for planning and implementing automation projects for the analytical labs.•Performed laboratory safety audits and conducted safety training as a member of the site safety committee.•Approved laboratory auditors’ data review for final approval.Novartis Pharmaceutical May 1996 to September 2001Scientist III, Analytical QC•Created and executed validation protocols for computerized and non-computerized analytical equipment.•Created and executed calibration analytical procedures for the entire QA analytical labs. Responsible for management of calibration and qualification records.•Repaired and maintained laboratory equipment. Set up new lab facilities•Responsible for instrumentation repairs, maintenance, calibration, and IQ/OQ/PQ of equipment especially HPLC equipment. Scientist I, II, June 1989 to May 1996•Performed complete analytical testing of in process and finished drug products. Testing included Assay, content uniformity, impurities, Identification, and dissolution testing.•Used HPLC (Waters, HP, and PE), UV Spectrophotometers, Flame photometers, FTIR, Dissolution Apparatus, and GCs.