• Managed the project for equipment installation qualification (IQ), and variable test method validation (VTMV) execution for coordinate measuring machine (CMM) O-Inspect 322 & Calypso 2018 Software validation, SOP writing and training. Also troubleshoot CMM equipment.• Managed the project for Equipment IQ /OQ and VTMV for Keyence WI-5000 for measuring of the energy Director of DPT Cap’s, SOP writing and training. • Trained engineers in photochemical etching.• Dimensional measurements using Micro Vu, Deltronic, DinoLite Microscope, Keyence 5000 microscope for support in DOE projects. • Self-Trained in Plastic Mechanical Properties and testing techniques at Mettler Toledo website.• Capital project approval for the Flow Bench CCO Test equipment acquisition, software and hardware integration. Capital project for Humidity Chambers capability.• Product Stewardship assessment and quick response to tenders. • Procured of new equipment for NPD R&D Laboratory, benches working area with drawers, electronic equipment procured, solvent and reagents purchases. • Created method for Instron 3344 Pull test for Oligon tubing samples and completed SOP • Develop Keyence 5000 Microscope Test Method and SOP Area Determination for Oligon.• Refurbished extraction hood and saved 5K in cost. • Developed photochemical etching method for Thermal filament. Selecting and procuring equipment, chemicals, photoresist and polyimide film.

Chromogenic Method Validations and HPLC method validation, SOP for laboratory instruments. Validation• Acquired the high-pressure liquid chromatography (HPLC) method technology required for the analysis of Benzalkonium concentration in raw material, solution and final product required to complies with FDA regulations requirements in medical devices, HPLC 1260 was validate and implement by 2016. • Equipment performance qualification (PQ), Test Method Validation (TMV) execution for Heparin determination using a Chromogenic method using a Sysmex CA 1500• Capital Project approval for HPLC equipment acquisition, IQ for computer used in HPLC addendum documentation• Worked in the laboratory layout and organization of the Heparin lab for the HPLC room, EHS hood evaluation acquisition and safety issues • Purchased of new equipment for laboratory fume hood, laboratory bench and cabinets, HPLC equipment, solvent and reagents purchases.

Raw Material Data Reviewer.• Analytical pharmaceutical ingredients and excipients review by USP/NF, EP, JP, JPE and all wet chemistry and general laboratory test data reviewer, also Empower HPLC data review and approve. • Spectroscopic Fourier transform infrared (FTIR), ultraviolet & visible (UV/VIS) data review, atomic absorption (AA), refractive Index (RI), HPLC and gas chromatography (GC) data from Empower 2.0

QA Specialist IILaboratory data reviewer of Raw Materials for several clients to secure the highest quality standard in accordance with client’s specifications. Guarantee that the laboratory is in compliance with procedures and following FDA GMP/GLP regulations and general regulatory requirements. Supervise and confirm best Quality Control practices within the laboratory. Also give support to different quality areas such as the equipment /qualification program and auditing of data. Review all Laboratory chromatographic data using Empower 2 and LIMS and approve final reports.

QA/QC Auditor Laboratory ChemistReview all Laboratory raw data (Empower 2, LIMS, notebooks, Test Worksheets) and finals reports. Assist in Laboratory investigations and performs the investigative analysis. Provide support to laboratory. Quality Audit data for CQ and BQ at a parenteral facility. Laboratory GDP audits and walk thru lab inspection. Laboratory Investigation Support team. Investigation preparation using Track wise computer system. Comparative gap assessment evaluation of Raw Material Methods with compendia USP/NF, EP, JP.•Comparative assessment evaluation of Raw Material methods with compendia USP/NF, EP, JP. gap analysis help avoid future deviations in laboratory testing. •Laboratory good documentation practices (GDP) audits and chromatography data review from external laboratory. • Laboratory batch record review for final release in QA.

Contractor by BES Consulting Group (Analytical Laboratory Scientist) Transfer products for SNS project, laboratory analyst and Empower 2 data reviewer. Transfer Analytical Methods and execute cleaning protocols for Pristiq, Aldactazide/Aldactone. Support Validation team on Finished Product Methods for Calan, Zyvox. Performed dissolution for Inspra / Eplerenone, Dilantin 30mg, 100 mg for solid dosage capsules and tablets analyzed by UV or HPLC.• Performed preventive maintenance & calibration for lab equipment on HPLC 1100, Water HPLC Alliance Waters 2695, GC Agilent 6890 (HP), UV/VIS, AA Perkin Elmer , balance calibration, FTIR, safety hoods preventive maintenance, dissolution bath prednisone calibration by USP. • Equipment validation IQ/OQ

Analytical Chemist & Lab Auditor / QC Lab.Laboratory Supervisor and Performed Analytical testing: GC Agilent System for residual solvent analysis, Drug Content by HPLC, ID test by UV-VIS and Raw Material Testing by FTIR. Also troubleshoot these equipment’s. Assist in laboratory investigation reports and out of specification (OOS) data interpretation. Review Analytical Data by Empower 2.0 to comply with the regulation cGMP, GLP and GDP for final disposition of lots. Standard operating procedure preparation & Subject Mater Trainer for Lab. Analyst Kaizen and 5s+1 certified for Laboratory LATCP, Six Sigma and yellow belt certified.

Analytical Chemist/ QC Lab. Laboratory Supervisor and Lab. Coordinator for four years in Rolaids finishes products, stability and complaints. Analytical Assay testing in by ICP-OES, AA, GC and Automatic Titrator for finished products, stability and complaints. Laboratory metrics performed by Excel to determine Cycle time. Approve Rolaids and Efferdent lots by LIMS and SAP. Involved in Validation Projects for consumer products. Performed Lab. Investigation report for non-conformance lots and complaint product. Automatic Titrator, AA and ICP trouble shooting also SOP trainer & SOP preparation.