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Cytogenetics, Quality Control Specialist

Description:
The QC Technician will perform work in connection with Cytogenetic based assays. The laboratory is a core analytical facility involved in the development and application of state of the art techniques in the analysis of cellular genetic markers. The company applies the assay technology toward assisting in the diagnoses and treatment of cancer.
Duties:
Transcribing FISH and molecular results into the LIMS system.
Pre-QC and Post-QC of Cytogenetics and Molecular reports
Maintain CAP PT paperwork, temperature logs, control logs for FISH and cytogenetics
PI data entry for biweekly meetings
Develop, review, and revise SOPs for test methods, competency assessment, quality control, reporting, and CAPA under CLIA, CAP and NYS guidelines under the guidance of the laboratory director.
Monitoring of Proficiency indicators in cytogenetics laboratory and provide routine reporting of variances to clinical operations and Lab Director
Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations
Recommend, create, implement, and update SOPs, as necessary, to improve processes, and support compliance.
Assist in compiling validation data for new assays in cytogenetics and FISH.
Communicate with monitors and auditors of clinical trials as needed.
Assist supervisor/technicians with CGI database and Excel macros. Submit repeat assay and re-analysis requests.
Assist client services with technical, sample, or assay-related client questions.
Monitor sample flow and turn-around time.
Communicate with Accessioning, Client Services, Histology, Microdissection and PCR when samples/assays are tardy, missed, need to be repeated, or to resolve information discrepancies.
Format, quality review, and provide research/clinical trial reports to clinical trials team.
Prepare and review CAPAs and deviation reports.
Communicate with clinical trial teams sample logistics, obtain pertinent information, resolve discrepancies, and report assay results.
Qualifications:
Bachelor of Science Degree, preferably in a biology or math related field
Microsoft Word and Excel proficient
Effective communication skills (both written and verbal)
Previous experience with FISH/Cytogenetics preferred
Reporting:
The QC Technician will report to the Director of Cytogenetics and will be expected to carry out the tasks assigned by his/her leads in a timely manner. The QC Technician will perform data entry, analysis, archiving, and reporting as per SOPs. It is the responsibility of the QC Technician to notify his/her leads and/or the Medical Director immediately about situations or issues that can adversely affect the assay results. The QC Technician will abide by the rules and regulations of the company regarding safety, patient confidentiality, data integrity and confidentiality, and will also follow all applicable regulatory guidelines in the course of his/her work.
Cancer Genetics is an Equal Opportunity / Affirmative Action Employer


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