Lab Quality Assurance Manager

Silver Spring, MD
Jun 05, 2019
Jul 20, 2019
Full Time
Lab Quality Assurance Manager
Key Role:
Implement and sustain quality and safety across the government and public health sectors. Ensure the reliability, reproducibility, and timeliness of laboratory investigational results to facilitate decision making in almost all aspects of health services. Work on a comprehensive quality management system that ensures recognized standards and oversight mandates are adhered to, thereby enhancing the reliability, reproducibility, and timely collation and production of laboratory data. Apply expertise in the implementation of quality management systems that ensure accredited regulatory compliance, including quality standards, such as Clinical Laboratory Improvement Amendments (CLIA), Good Laboratory practices (GLP), International Standards Organization (ISO), or Quality System Regulation (QSR). Apply expertise in supporting the analysis, development, and implementation of quality management systems within the laboratory environment and the realm of management and workflow operations, apply advanced principles, theories, and concepts to support quality management systems and technical expertise to support and implement quality initiatives, execute technical reviews, regulatory analysis, and systematic assessments of quality-driven processes and procedures, assist with identifying areas for improvement and provide recommendations for streamlining and standardizing quality processes, use independent judgment to accomplish objectives, be self-motivated and directed, determine and develop an approach to solutions, independently, maintain supervision of a team of staff, and interact with stakeholders directly.

Basic Qualifications:

-5+ years of experience with working in an accredited or non-accredited laboratory

-3+ years of experience with quality standards, including ISO 9001:2015, ISO/IEC 17025, or CLIA

-Experience with writing SOPs and other laboratory documents, conducting basic laboratory techniques, and collating and analyzing data

-Experience with communicating concepts of quality management, quality assurance, and process improvement

-Experience with computer work

-Knowledge of laboratory regulatory and compliance, quality, and safety

-Ability to work well in a team environment that promotes inclusiveness and communication among team members

-Ability to obtain a security clearance

-BA or BS degree

-Quality Certification, including Certified Quality Auditor or ISO Lead

Additional Qualifications:

-Experience with Microsoft Office Suite, including Word, Excel, Access, and SharePoint

-Experience with Visual Basic for Applications (VBA) coding a plus

-Ability to manage and execute multiple tasks, prioritize, and meet deadlines

-Possession of excellent planning and organizational skills, including being a self-starter who functions independently

-Possession of excellent oral and written communication skills

-BA or BS degree in Biological Science, Microbiology, Biotechnology, or Biomolecular Engineering preferred; MA or MS degree a plus

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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