Janet Salazar

Clinical Experience and Research/Product Development Responsibilities:

- Conducted clinical sample receiving and accessioning under the supervision of CLS professionals.
- Performed nucleic acid isolation, PCR amplification, and real-time PCR quantification, guided by CLS oversight.
- Executed capillary electrophoresis and evaluated assay quality control under the direction of CLS professionals.
- Tested clinical samples using COVID-19 detection tests and shadowed CLS personnel in analyzing COVID-19 results, enhancing my understanding of data interpretation.
- Contributed to the developmental testing of COVID-19 detection tests in accordance with FDA standards, including:
- EUA (Emergency Use Authorization) for the DxTerity SARS-CoV-2 RT-PCR Test issued on 08/21/2020.
- EUA for the DxTerity SARS-CoV-2 RT-PCR CE Test issued on 08/28/2020.
- Involved in research and development projects related to the COVID-19 saliva-based test and analyzed results from testing.
- Conducted characterization, verification, and validation studies to support 510(k) submissions to the FDA for the REDI-Dx Assay project.
- Executed quality control and clinical sample testing, and performed studies for the Autoimmune Profiler (AIP) Assay for Celgene.
- Drafted and reviewed protocols, compiled data analysis, and presented findings weekly in PowerPoint format to the Product and Development team.
- Performed internal audits to ensure compliance with BS EN ISO 13485:2016 and 21 CFR Part 820 GMP standards for medical devices.
- Managed data entry for participants in clinical trials and maintained oligonucleotide inventory control.
- Conducted laboratory equipment maintenance and ensured daily clean-up.
- Accumulated over 7 years of expertise in developing and validating diagnostic assays utilizing DxTerity's DxDirect technology, covering pre-analytical, analytical, and post-analytical phases.
- Proficient in serial dilution techniques, including sample dilutions and buffer titrations.
- Possess more than 5 years of experience in data analysis, evaluating results, identifying root causes, and strategizing follow-up studies.
- Well-versed in automated instrumentation, molecular procedures, and quality control protocols.
- Independently executed laboratory experiments while effectively collaborating with team members to develop efficient work plans and meet time-sensitive milestones.
- Received and processed biological samples using SLIMS, and authored internal audit reports, NCRs, and work instruction documents.
- Evaluated emerging technologies for potential integration into ongoing research initiatives.

Clinical Experience and Research/Product Development Responsibilities:

- Conducted clinical sample receiving and accessioning under the supervision of CLS professionals.
- Performed nucleic acid isolation, PCR amplification, and real-time PCR quantification, guided by CLS oversight.
- Executed capillary electrophoresis and evaluated assay quality control under the direction of CLS professionals.
- Tested clinical samples using COVID-19 detection tests and shadowed CLS personnel in analyzing COVID-19 results, enhancing my understanding of data interpretation.
- Contributed to the developmental testing of COVID-19 detection tests in accordance with FDA standards, including:
- EUA (Emergency Use Authorization) for the DxTerity SARS-CoV-2 RT-PCR Test issued on 08/21/2020.
- EUA for the DxTerity SARS-CoV-2 RT-PCR CE Test issued on 08/28/2020.
- Involved in research and development projects related to the COVID-19 saliva-based test and analyzed results from testing.
- Conducted characterization, verification, and validation studies to support 510(k) submissions to the FDA for the REDI-Dx Assay project.
- Executed quality control and clinical sample testing, and performed studies for the Autoimmune Profiler (AIP) Assay for Celgene.
- Drafted and reviewed protocols, compiled data analysis, and presented findings weekly in PowerPoint format to the Product and Development team.
- Performed internal audits to ensure compliance with BS EN ISO 13485:2016 and 21 CFR Part 820 GMP standards for medical devices.
- Managed data entry for participants in clinical trials and maintained oligonucleotide inventory control.
- Conducted laboratory equipment maintenance and ensured daily clean-up.
- Accumulated over 7 years of expertise in developing and validating diagnostic assays utilizing DxTerity's DxDirect technology, covering pre-analytical, analytical, and post-analytical phases.
- Proficient in serial dilution techniques, including sample dilutions and buffer titrations.
- Possess more than 5 years of experience in data analysis, evaluating results, identifying root causes, and strategizing follow-up studies.
- Well-versed in automated instrumentation, molecular procedures, and quality control protocols.
- Independently executed laboratory experiments while effectively collaborating with team members to develop efficient work plans and meet time-sensitive milestones.
- Received and processed biological samples using SLIMS, and authored internal audit reports, NCRs, and work instruction documents.
- Evaluated emerging technologies for potential integration into ongoing research initiatives.

In this role at a CLIA-certified, CAP-accredited laboratory, responsibilities include:

-Oversee shipping and receiving of laboratory supplies, manage inventory, and ensure proper accessioning and storage of clinical samples.
-Work under the supervision of a CLS to gain experience in nucleic acid isolation, PCR amplification, and instrument maintenance.
-Conduct R&D experiments and characterization studies for the REDI-Dx assay, and perform data entry for clinical trial participants.
-Evaluate assay quality control and document laboratory processes.
-Complete training in lab safety protocols and HIPAA compliance.

In this role at a CLIA-certified, CAP-accredited laboratory, responsibilities include:

-Oversee shipping and receiving of laboratory equipment and consumables, inventory control, and proper accessioning and storage of clinical samples.
-Work under the supervision of a CLS to gain hands-on experience in nucleic acid isolation, PCR amplification, real-time PCR quantification, and instrument maintenance, including liquid handlers and genetic analyzers.
-Evaluate assay quality control and document laboratory processes to ensure compliance.
- Complete training in lab safety protocols, including bloodborne pathogens, chemical hygiene, and HIPAA compliance.