Quality Assurance Analyst I
The QA Analyst I will primarily assist in organization-wide functions such as electronic Quality Management System support, including but not limited to reviewing and uploading documents and maintaining training plans. Additionally, there will be a broad scope of work with the Clinical Quality team such as maintenance of equipment usage and maintenance logs, reviewing data generated from the CLIA lab and conducting internal audits per the ISO 15189 standard.
- Review submitted documents for meta-data accuracy and upload document into the electronic Quality Management System
- Assist with training program activities such as serving as a training coordinator for Quality and other groups as required.
- Assist in maintaining CLIA and other third-party licensures and accreditations, including ISO 15189, College of American Pathologists and ISO 13485.
- Review laboratory data sheets and Quality Control packets for the samples and reagents in the Clinical Lab.
- Assist in preparation for inspections conducted for CLIA license, client inspections and third-party accreditors such as CAP and ISO.
- Assist in internal audits for both Clinical and Manufacturing Operations as required and in accordance with ISO 15189 and ISO 13485 respectively.
- Assist in close of Clinical Quality records such as Quality Events, CAPAs and deficiencies from inspections.
- Assist with daily office tasks and procedures, compile documents as directed and rework outdated procedures.
- Assist QA Director and Team Lead in tasks as assigned.
REQUIRED EDUCATION AND EXPERIENCE
- 1-3 years of experience working in Quality, preferably in the Biomedical or Diagnostic industry.
- Required: Bachelor’s degree in Science, preferably in Biotechnology or in the Biology sphere.
- Familiarity with CLIA, CAP, ISO 15189 and ISO 13485 standards preferred.
- GMP Document Management Change Management experience preferred.
- Experience working with eQMS preferred.
ABOUT PERSONAL GENOME DIAGNOSTICS
Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information
from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy
genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer
researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic
technologies for drug development and clinical practice.
Please submit applications (cover letter and resume) to HR@personalgenome.com
Special consideration will be given to internal PGDx employees who apply.
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