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