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Quality Specialist
Ref No.: 18-16625
Location: San Jose, California
Provides Quality Assurance and regulatory compliance support for the Ariosa Clinical Laboratory.
Participates on cross functional teams to assure effective implementation and adherence of QA
initiatives and process improvement.
Monitors the Occurrence Management system to resolve Client and CAPA investigations and to assist with system administration including issues encountered with forms, logins, and training
Reviews and provides guidance for various non-conforming situations and investigation
Analyzes complex production and quality trend data to identify and solve problems. Develops systems for recording, evaluating, and reporting quality and
reliability data.
activities, evaluates root cause and corrective actions, and ensures documentation is complete and
Participates in customer complaint investigations for incidents or events.
Conducts internal audits of quality and laboratory support systems
Provides assistance in administration of the environmental monitoring system. Provides user assistance
and back up support to engineering services during facility upgrades or moves.
Provide Quality System and CLIA laboratory training as required.
Monitors and maintains Quality System logs; Generates monthly and quarterly reports as assigned.
Provides assistance in maintaining training and competency records

Working knowledge of CLIA, CAP, and state regulations for a Clinical Laboratory, preferred
Demonstrated understanding of quality systems and procedures
Effective oral and written communication skills
High attention to detail
Excellent organizational skills
Proficient in MS Office applications
Excellent people skills: tact, collaborative, able to communicate with personnel at various levels in the organization
Assertiveness in enforcing department guidelines
Ablility to work with minimal oversight

M-F 8/5