Senior Quality Assurance Specialist

Job Description

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