6 months contract-to-hire position for a Biological Quality Assurance Officer in Atlanta, GA
We are currently seeking a Quality Assurance Officer to assist in auditing, reporting, implementation, and maintenance of Quality System processes for laboratories performing diagnostic testing of patient specimens, surveillance testing, research activities, reference material production, proficiency test program management, etc. The Quality Assurance Officer will be part of the QA team with continuous improvement of a Laboratory Quality System that complies with Clinical Laboratory Improvements Amendment (CLIA), Good Laboratory Practices (GLP) per 21 CFR Part 58, Good Manufacturing Practices (GMP) per 21 CFR 820, ISO 13485, ISO 15189, ISO/IEC 17025, ISO 17034, ISO/IEC 17043, and/or ISO 9001, as appropriate, by completing audits of laboratory quality systems. Relocation support is not available for this position.
• Formal Laboratory QMS implementation and operation
a. ISO/IEC 17025:2017 implementation expertise (essential)
b. ISO 15189 implementation expertise
c. CLIA and QSR QMS integration experience
• Laboratory accreditation through an accredited accrediting body (i.e., A2LA, ANAB, NIST, or PJR)
• Laboratory test method development, characterization and validation
c. Molecular detection and identification methods
• Process development, validation and documentation
• Reference material and certified reference material planning, production, labeling, and distribution
• Proficiency testing program planning, production, distribution, and evaluation
• Experienced and credentialed quality auditor
• Knowledgeable of ISO 13485 requirements, and QSR alignment
• Knowledgeable of ISO 17034 and ISO/IEC 17043 requirements
• Risk management and risk assessment
• Excellent communication skills (writing, verbal, presenting)
THE FOLLOWING REQUIREMENTS MUST BE MET TO BE CONSIDERED FOR THIS POSITION:
• Requires Bachelor's of Science degree with emphasis in biomedical or other life science discipline. Master's degree strongly preferred.
• 5-10 years of direct experience in Quality Assurance wiithin one or more of the following areas: biological products manufacturing, biopharmaceuticals, vaccines, in vitro diagnostics (IVD), clinical laboratory, or similar area.
• Demonstrated experience coordinating the implementation of laboratory quality systems for ISO accreditation.
• Strong interpersonal, oral and written communication skills.
THE FOLLOWING IS DESIRED, BUT NOT REQUIRED TO BE CONSIDERED FOR THIS POSITION:
• Quality assurance system implementation experience in a government laboratory facility.
• Experience with SharePoint O365, and SharePoint Online migrations and modernizations