Quality Assurance Officer

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

Qualifications

• Bachelor’s degree in science, or equivalent years of experience (Required)
• 3+ years of experience in a regulated commercial lab environment (Required)
• Knowledge of scientific principles and of state regulations and ISO and TNI Standards (Required)
• Excellent oral and written communications skills
• Strong self-initiative and resource utilization
• Advanced English language skills
• Advanced mathematical and reasoning skills
• Solid critical thinking skills to anticipate and solve problems in a systematic manner