Samarth Christy

• Carry out quality control testing required for manufacturing and release of EasyScreen products as per GSL internal procedures and specifications.
• Perform DNA/RNA extraction, RT-PCR and qPCR for molecular diagnostics, ensuring accurate and reliable results.
• Do stability testing of products as required to support shelf-life allocations and extensions.
• Implementation of the production work plan according to agreed timelines.
• Perform production and quality control of EasyScreen diagnostic kits when required.
• Record and action any observed non-conformances or stock discrepancies.
• Liaise with Production and R&D groups as appropriate.
• Review and update production documentation including BWIs and SOPs.
• Follow manufacturing instructions meticulously and record all work efforts where required.
• Maintenance of appropriate safety, record keeping and quality requirements.
• Assist the Production team to effectively transfer products from development to.
• Assist manufacturing activities including stock management, reagent manufacture.
• Stability and contamination control of products.
• Compliance with Quality and Regulatory requirements.
• Liaise with Production, Quality and Regulatory Affairs teams to ensure all manufacturing activities comply with QMS and regulatory requirements (including FDA, HC, TGA and IVD).
• Assist with CAPA investigations as required.
• Performing extraction and RT-PCR for Covid samples.
• Operating machines like ANDIS (3-D MED) for extraction of genetic materials, running real time Polymerase chain reaction on CFX (Bio-Rad) machine.
• Carrying out GeneXpert Test on samples for urgent or invalid samples.
• Checking late list and prioritizing sample based on the list.
• Conducted test to identify presence of Neisseria Gonorrhoeae and Chlamydia Trachomatis on Cobas 4800 machine.
• Executed test for finding out presence of Human Papillomavirus in the samples using Cobas 4800 machine.
• Processed samples for Methicillin-Resistant Staphylococcus Aureus (MRSA) on Vela diagnostic machine.
• Reporting to the manager for any positive samples for above mentioned tests.
• Troubleshooting for machines as and when required.
• Informing managers about the stock of regents well in advance for ordering new kits.
• Speaking to doctors and adding the tests on the samples if required. Also, letting them know about the results if necessary.

· Performing extraction and RT-PCR for Covid samples.

· Operating machines like ANDIS (3-D MED) for extraction of genetic materials, running real time Polymerase chain reaction on CFX (Bio-Rad) machine.

· Carrying out GeneXpert Test on samples for urgent or invalid samples.

· Checking late list and prioritizing sample based on the list.

· Conducted test to identify presence of Neisseria Gonorrhoeae and Chlamydia Trachomatis on Cobas 4800 machine.

· Executed test for finding out presence of Human Papillomavirus in the samples using Cobas 4800 machine.

· Processed samples for Methicillin-Resistant Staphylococcus Aureus (MRSA) on Vela diagnostic machine.

· Reporting to the manager for any positive samples for above mentioned tests.

· Troubleshooting for machines as and when required.

· Informing managers about the stock of regents well in advance for ordering new kits.

· Speaking to doctors and adding the tests on the samples if required. Also, letting them know about the results if necessary.

Amended general laboratory duties including maintenance of machines both daily and weekly.

• Prepared samples for analysis by mixing, blending, and weighing, in accordance with sample/analysis requirements and preparation methods.
• Performed routine analysis, validations, and project work in an efficient and effective manner.
• Ensured external and internal clients’ requirements.
• Planned efficient utilization of laboratory materials.
• Operated, calibrated, and maintained equipment/instruments as required.

o Data entry of COVID-19 patients.

o Separated forms based on the area.

o Prioritized data entry based on the priority list.

o Worked in fume hood.

o Pipetting reagents and samples.

o Added samples to 96 well plate for DNA extraction.

o Complied various reagents and chemicals to make master mix.

o Prepared samples for PCR machine.

o Conducted PCR test of samples.

• Applied strong written communication skills to present findings during internship in form of a report.
• Conducted DNA & RNA extraction.
• Diagnosed mutations from patients' sample using DNA & RNA extraction technique.
• Utilized state of the art equipment such as a next-generation sequencer.
• Executed tests such as CTFR mutation, MTHFR mutation, Real-time PCR for gene quantification.