•Coordinated equipment calibration and preventive maintenance scheduling. •Preparation of Dehydrated Culture Media, reagents, solutions, buffers and chemicals for facility.•Configured, managed, and performed molecular testing, including real- time PCR, to rapidly identify and characterize potential pathogenic bacterial, nucleic acid extraction, assay preparation and laboratory data analysis/interpretation in BSL-2 environment. •Performed microbiological testing per USP and BAM guidelines, microbial testing of a wide range of FDA regulated products such as pharmaceuticals (solid dosage, creams and lyophilized), raw materials and finished products. Bioburden testing, LAL, Stability and Batch release testing.•Effective communication with internal and external customers, peers and supervising.•Assured the integrity and quality of analytical data produced are adhering to all relevant in-house and client SOPs and methodologies and following GMP requirements.•Provided Microbiological testing by, Standard Methods for the Examination of Water and Wastewater and AOAC methods.•Maintained laboratory cleanliness by labeling, section designation, and segregation of materials and glassware in an orderly fashion.

•Reviewing and Improving Bacterial Endotoxin Test ((BET), Sterility, Bioburden and Microbiology/Chemistry Standard Test Methods SOP’s. •Coordinated project to insure that all analytical instruments were in compliance for IQ, OQ, PQ and documentation was correct for a pre inspection before ISO 17025 certification campaign.•Conducted internal laboratory audits, discussed issues that were discovered during final report, identified potential compliance issues, find laboratory investigations, deviations and implemented corrective actions to prevent them as well as monitoring the internal quality systems to ensure compliance with FDA/CVM.•Worked extensively with this company establishing systems that would be compliant with applicable GMP/QMS regulations using Master Control Software package. •Performed calibration on warehouse freezers, Stability Chambers, analytical Instruments, electronic balances, autoclaves, etc.

•Determined identity of raw material by physical appearance, bulk and tapped density, particle size distribution, and viscosity in accordance with USP specification.•Conducted finished product testing on solid dosage forms to determine uniformity, potency (with respect to % Label Claim), hardness, and friability in accordance with USP specification.•Analysis of raw materials and finished products to determine identity and /or potency by IR, UV-Visible, TLC and HPLC while ensuring adherence to GMPs.•Prepared test solution and volumetric solutions, and perform accurate dilutions and standardization according to company SOP’s.

•Provided interim staffing for IVF centers for leaves, absences, pregnancy and staffing shortages. •Conducted analysis to address low pregnancy rates that increased by optimizing the pregnancy rates from 33% to 56%. •Trained personnel and set up of laboratory instrumentation and troubleshooting•Executed external vendor audits and internal audits to assess compliance with applicable regulatory guidelines ICH, FDA Regulations and for multiple projects and clinical studies.•Provided validation activities for Clean room 10,000 certification IVF Laboratories. National and International audit performed in Russia, India and Puerto Rico, for the College of American Pathologist (CAP). •Clinical and quality control assays (semen analysis and mouse embryo culture assay) •Responsible for Clinical Andrology procedures (semen preparation for intra-uterine insemination and cryopreservation of sperm) •Independently performed ART procedures (retrieval and identification of human oocytes, In Vitro Fertilization (IVF), Intracytoplasmic Sperm Injection (ICSI), Embryo Biopsy, and Embryo Transfer, Embryo and Blastocyst Cryopreservation. (Programmed Control Rate freezing and Vitrification)Coordinated and performed first Preimplantation Genetic Diagnosis (PGD) cases that included screening for aneuploidy and single gene analysis of chromosomes.(Savannah, GA. and San Juan, Puerto Rico)

• Achieved laboratory benchmarks to accomplish significant increases in pregnancy rates, take home baby rates and viable embryo for transfer by using Intercytoplasmic sperm injection. • Conducted Quality Control analysis to address consumption of reagents and repeat testing which led to a 25% increase in laboratory testing revenues. • Design of laboratory procurement and setup of laboratory instrumentation. Troubleshooting of instrumentation for validation, calibration and operation

Lab SupervisorConsultantTechnical