Baltimore, MD

Quality Assurance Manager

Seniority Level

Mid-Senior

Industry

Biotech/Pharma

Employment Type

Full-time

Thrive Earlier Detection is searching for a Manager, Quality Assurance. This position will lead QA activities to ensure compliance with CLIA, CAP and FDA regulations and requirements. The Quality Assurance Manager is responsible for developing, maintaining, and monitoring quality assurance operations, quality documentation, and supporting laboratory operations in compliance with Clinical Laboratory Improvement Act (CLIA) and Quality System Regulations. Will work across multiple sites’ quality departments in enhancing systems, workflows and tools used for quality systems management. This position will be responsible for supervising QA professionals.

Responsibilities

  • Assist in development and implementation of FDA compliant (QSR) Quality System, may take lead on elements of QSR implementation
  • Support initiatives for certification of the quality compliance programs at each Thrive worksite
  • Works with the Clinical Laboratory Director and QA Director to review all Quality documents for regulatory compliance with FDA, CLIA and CAP
  • Demonstrate strong proficiency in the application of the Corrective And Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources
  • Provide review and feedback on validation plans and reports
  • Provide supervision of QA associates/specialists
  • Ensure proper management of deviations
  • Responsible for maintaining, updating and versioning of policies and protocols
  • Ensure that record keeping under FDA/GLP requirements are attributable, legible, contemporaneous, original and above all, accurate
  • Ensure that equipment under FDA/GLP standards are properly maintained, cleaned and inspected on a routine basis per SOPs. o Manage IQ/OQ activities of new equipment and oversee PM/calibration activities. o Responsible for ensuring that equipment standards are tested, calibrated and standardized before patient testing, and that all must be documented and approved. o Manage creation and modification of equipment SOPs
  • Provide routine review of incident and deviation logs
  • Manage employee training files o Review credentials to ensure compliance o Manage training matrix

Qualifications

  • Bachelor’s degree in a relevant chemical, physical, or biological field from an accredited college or university
  • 6-10 years of experience in laboratory operations, quality control and / or engineering positions
  • At least 2 years of direct Quality Assurance experience
  • Able to conduct external audits of vendors and subcontractors
  • Able to deliver results on schedule in a fast-paced, dynamic environment
  • Demonstrated knowledge of GXP regulations and guidance documents
  • Experience in the diagnostics industry strongly desired
  • Quality Assurance experience in working within companies having CLIA and CAP certified laboratories
  • Experience in evolving and scaling Quality System processes as a company grows
  • Experience in managing Corrective and Preventative Actions (CAPA), change control, and deviation (nonconformance) systems
  • Experience in performing and facilitating root cause analysis investigations
  • Knowledge of HIPAA and history of working with confidential patient information
  • Demonstrated interpersonal skills in working with teams and problem solving
Are you qualified?

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