Quality Control Specialist Iii

Support the laboratory quality management system (LQMS), which includes, monitoring the quality of serologic and diagnostic testing to ensure developed diagnostics and reagents meet quality standards. Including monitoring assay performance, equipment monitoring, reagent lot testing, and other quality tasks.

Compensation & Benefits:

Pay commensurate with experience.

Full time benefits include Medical, Dental, Vision, 401K and other possible benefits as provided. Benefits are subject to change with or without notice.

Quality Control Specialist III Responsibilities Include:

• Support and comply with program’s specimen management policy
• Conduct site visits and quality audits
• Maintain all related records and review batch production and preparation records and master production files for FDA submission
• Assist in the development, editing, and validation of Standard Operating Procedures that support manufacture and quality control processes
• Update equipment master lists, calibration, and maintenance logs
• Perform quality control and CLIA certified testing
• Development of quality assurance and control materials for evaluation of data
• Analyze the quality and validation of research and diagnostic methods
• Support activities associated with 510K, and Emergency Use Authorization (EUA) developed kits
• Perform evaluations of new or alternate laboratory equipment platforms and biological reagents
• Maintain staff records and database
• Perform molecular and virological QC testing
• Maintain supplies inventory, order, and inspect products under applicable guidelines and regulatory requirements
• Comply with LQMS program requirements and applicable CLIA, GLP, GMP, ISO, and FDA regulatory requirements
• Assist with non-conforming event analysis and corrective action improvement efforts
• Performs other job-related duties as assigned

Quality Control Specialist III Experience, Education, Skills, Abilities requested:

• BA, BS or MS. Experience with laboratory quality management systems.
• Certified Quality Auditor certification or equivalent may be required
• Possess strong verbal and written communication skills; demonstrate ability to organize vast amounts of data
• Approximately 4 years’ experience.
• Ability to work independently and in a team environment
• Viral/Influenza experience is a plus.
• Proficient with Microsoft Word, Excel, and PowerPoint
• Knowledge of CLIA, GLP, GMP, ISO, and FDA regulatory requirements
• Excellent written and verbal communication
• Must pass pre-employment qualifications of Cherokee Federal

Company Information:

Cherokee Nation Operational Solutions (CNOS) provides support, services, and solutions to federal and commercial customers. The company takes a personalized approach to solving our clients' toughest challenges, helping you make the most of your skills. CNOS is part of Cherokee Federal – a team of tribally owned federal contracting companies. For more information, visit cherokee-federal.com.

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Similar Searchable Job Titles:

• Senior Quality Control Specialist
• Quality Control Analyst III
• Quality Control Supervisor
• Quality Assurance Manager
• Quality Systems Manager

Keywords:

• Statistical Analysis
• Process Improvement
• Quality Assurance
• Quality Management System
• Regulatory Compliance

Legal Disclaimer: Cherokee Federal is an equal opportunity employer. Please visit cherokee-federal.com/careers for information regarding our Affirmative Action and Equal Opportunity Employer Statement, Accommodation request, and Presidential EO 14042 Notice.