Senior Quality Assurance Specialist
2 weeks ago
Our East Syracuse, NY laboratory is looking for a Senior Quality Assurance Specialist to join their team The Senior Quality Assurance Specialist is responsible for aspects of data quality, integrity oversight, and for ensuring quality systems are functioning within QSM requirements and regulatory compliance, corrective action implementation for the location, ensuring all quality systems are functioning within QSM requirements and regulatory compliance. The Senior Quality Assurance Specialist participates in internal audits and other aspects of ensuring the Quality System. The Senior Quality Assurance Specialist reviews routine and validation testing.
Job Functions
Audits and reviews quality data quality according to existing documents and procedures
Manages, leads or participates to varying degrees in QA functions defined by ISO/IEC:17025, ISO/IEC:9001, DoD QSM, TNI Standards, and state specific requirements, as relevant to the site
Maintains the Quality Systems
Participates in review of investigations, impact assessments, and other specialized reviews and reports
May participate in customer audits and answering customer questions or resolving customer concerns
Prepares and/or reviews and approves department SOPs, worksheets, and data forms
Has working knowledge and experience in own discipline
Performs daily reviews of aspects of the quality system and operational activities
Performs training, including data integrity, quality systems, QC training, and other training as required
Performs laboratory and systems audits per assigned schedule
Participate in external audits from clients and regulatory agencies
Assists in maintaining regulatory certifications
Reviews and issues client reports in various electronic formats
Reviews PT results and reviews corrective actions as required
Assigns and archives logbooks for the laboratory and maintains inventory of logbooks as required (site specific)
Participates in review and/or processes annual MDL/LOD/LOQ Studies
Participates in aspects of managing PT samples and in-house blind QC samples
Maintains records of PT performance (site specific)
Maintains and updates QAPP worksheets (site specific)
Other QA duties as required
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