Quality Specialist - IVD

Los Angeles  ‐ Onsite
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Keywords

Description

Role and Responsibilities: Under the direction of the Vice President, Quality Assurance and Regulatory Affairs:
  • Develops written policies and procedures required for establishment of a QSR-compliant Quality System.
  • Works with Management and Staff to develop practical solutions to achieve regulatory compliance.
  • Trains Management and Staff on policies and procedures.
  • Performs internal audits to assess compliance, and works with Management and Staff to develop practical solutions to achieve compliance.
  • Assists in development of Quality Plans.
  • Maintains all records and documents within the Quality System.
  • Assures all products, processes and systems comply with DxTerity policies, procedures and specifications.
  • Performs supplier qualification, supplier audits and monitors supplier quality.
  • As a member of project teams, participates in the planning and execution of required validations
  • Oversees CAPA program effectiveness
  • Participates as assigned as a Quality representative on project teams
  • Assists in the development and monitoring of quality metrics.
  • ASQ Certification as Quality Engineer or Quality Auditor or equivalent.
  • Experience with product design controls during development of nucleic acid-based assays for disease detection and diagnosis or development of pharmaceutical products in a regulated environment, preferably in a company manufacturing diagnostics products for the clinical lab and/or doctor's office market.
  • Experience in planning, coordinating and documenting controlled studies, including protocols.


Desired:
  • Experience as an auditor for Federal and State inspections, ISO/ European Directives/ Notified Bodies, and/or U.S. FDA Quality System Regulatory Compliance inspections.
  • Technical knowledge of molecular biology and genetic testing laboratory practices (CLIA, ASR, IVD).
  • Training and experience in basic statistical analysis tools, Design of Experiments (DOE) and Six Sigma methodologies preferred.
  • Knowledge of safety precautions required for working with blood borne pathogens at Biosafety Level 1 and 2.


To find out more about Real please visit www.realstaffing.com
Start date
10/2013
From
Real Staffing
Published at
17.10.2013
Project ID:
614099
Contract type
Permanent
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