Quality Assurance Officer

Job Description

POSITION SUMMARY

The Quality Assurance Officer 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 Officer participates in internal audits and other aspects of ensuring the Quality System. The officer 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 System
• 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

EDUCATION AND EXPERIENCE

• 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)

KNOWLEDGE / SKILLS / ABILITIES

• Oral and written communications Skills : Advanced
• Self-initiative and Resource Utilization : Advanced
• Language Skills : Advanced
• Mathematical Skills : Advanced
• Reasoning Skills : Advanced
• Solid critical thinking skills to anticipate and solve problems in a systematic manner

Computer Skills

• Advanced computer skills in Microsoft Office suite required (Required)
20 days ago