CLS/ QA role – LOCATED in San Diego, CA
DIRECT HIRE, Day Shift (M-F), Salary OPEN
Skills:
· Assist in conducting and coordinating regulatory audits
· Maintain an inspection-ready lab system
· Ability to define problems, collect data from a variety of sources, both technical and non-technical, establish facts and draw valid conclusions and corrective actions
· Maintain a high level of collegiality, innovation, ambition, discipline, commitment and accountability
· Technical experience in Molecular Biology testing methods: Nucleic Acid Extraction, Real-Time Polymerase Chain Reaction (PCR), Real-Time PCR Data Analysis
· Experience with Specimen Processing (i.e. Accessioning, Problem Sample Resolution, Aliquoting, Dilutions, etc...)
Responsibilities:
- Assist in the design, implementation and maintenance of Quality Assurance procedures, documents and activities.
- Maintain an inspection-ready lab system and that company practices are in compliance with state, CAP, CLIA and good laboratory practices.
- Manage Document Control for company SOPs, policies, procedures & marketing material.
- Act as a resource for the pre-analytical, analytical and post analytical testing process to increase efficiency, reduce defect and increase quality.
- Assist with the Corrective and Preventative Action (CAPA) process for errors by leading investigations into Root Cause Analysis and timely problem resolution.
- Assist in the transfer of new processes and methods from R&D into clinical production.
- Assist in conducting and coordinating Quality /Process Improvement/Problem Resolution Training.
- Perform clinical testing of patient samples and data analysis with interpretation of test results for review and acceptance by the Medical Laboratory Director for the accurate release of patient test reports
Jenifer Capalbo
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SENIOR SCIENTIFIC ACCOUNT RECRUITING MANAGER
AEROTEK SCIENTIFIC LLC
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2275 Rio Bonito Way
Suite 160
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San Diego, CA 92108
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