Guruprasath S. Durairajan Email & Phone Number

Mountain Lakes, New Jersey, United States

Mountain Lakes, New Jersey, United States

New Jersey

Established & responsible for Quality Management / Quality Control / P.A.C.E. accredited Training Academy departments. Responsible for Technical Support (Complaints) department. Successfully launched initiatives such as ‘Road to Zero’ to create a closed loop – cross functional system that aims to reduce customer complaints through custom novel solutions• Mitigating risks by establishing necessary control as appropriate• Establish policies, SOPs, work instructions; record controls. Implement training matrix; provide QS training.• Identify key processes, define specifications, and oversee qualification & validation activities• Work directly with production, QC dept., to ensure Device Master Records (DMR) & Device History Record (DHR) requirements are met on a continuing basis• Work directly with IT on data management & software qualifications• Establish & manage purchasing control activities such as supplier management to ensure only quality raw materials, products & services are purchased & used• Work directly with receiving & QC to ensure that the raw materials, components, finished kits, instruments & other materials received are qualified before its use• Ensure that non-conforming products are identified, segregated & disposed properly• Ensure the customer & internal notifications are managed, issued & released• Work directly with technical support to review complaints & feedbacks to ensure performance & product’s quality conform to established specifications• Manage & perform internal audits, issue CAPA requests, monitor its effectiveness & documentation. Lead in external audits, respond to any CAPA & provide resolution• Periodic review of quality management documents, updating as needed and revision controls• Drive the development of metrics (KPI) for all areas of the QS, analyze quality data and report metric results at Management Reviews; lead continuous improvement activities; monitor the processes through Statistical Process Controls (SPC)

Staten Island, Ny 10304

A resource person to the NYS Department of Health, CLIA, CAP, CMS when there is a need for document review and compliance assessment.Regulatory Compliance:• Work with the Executive Management and Lab Director(s) to ensure all Federal and State regulations are met in all areas of service offerings.• Work with Lab Supervisor(s) and Medical Technologist and other support staff to ensure all Pre-Analytical, Analytical and Post Analytical phases of testing and sample handling are performed at the highest standards.• Prepare and have the laboratory ready for on-site surveys and inspections from regulatory agencies.Quality Management:• Identify & Implement new monitors and KPIs to improve processes.• Prepare & Implement new SOPs, update existing SOPs for overall quality improvement.• Validating new procedure and changes to the existing processes to ensure compliance.• Work with Lab Director(s) in establishing and implementing CAPA when necessary.• Facilitate quality improvement, by including members from all disciplines of the lab.• Constant analysis and reporting of QC data, sample counts, peer group data, bias and trends.• Be proactive, using statistical analysis to find new avenues for improvement.Business Analytics:• Cost cutting, business negotiations, pricing and overall daily operation regulations, revenue improvement and cost minimization.• Daily monitoring of account receivables and expenses; Provide effective and efficient administrative direction, including budget planning and controls in conjunction with owners of the laboratory.LIMS Duties:• Highly proficient in LIMS; configuration, database, user training and interface management.• Make necessary day to day changes and updates in LIMS; system validations.• Interface validation & maintenance, support, new user/group creation and access privilege limitations.• Periodic monitor, review of results, trending analysis and report appropriately.

Brooklyn, Ny

# Assisted in the study of creep and electrical properties of various polymers under mechanical force

Brooklyn, Ny

# Assisted in the manufacturing of Methyl Myristate from Myristic acid using engineered Candida tropicalis by fermentation

Chennai, India

# Assisted in investigating the anti-ulcer effects of selected medicinal plants using the Pylorus ligation method in Sprague Dawley Rats

Masters, Biotechnology

Bachelors, Biotechnology