Job Description:
The individual in this position is responsible for performing day-to-day quality assurance (QA) activities, managing QA processes such as document management, internal audits, instrumentation change control, corrective and preventative actions, and assay validation planning to ensure compliance to GCLP requirements as the Client Oncology Clinical Research Laboratory (POCRL) develops, validates, and performs clinical trial assays. In addition, the position is responsible for providing QA support for clinical trial assay activities, including receipt, accessioning, and internal tracking of clinical trial biospecimens.
RESPONSIBILITIES:
• Maintain, troubleshoot, and monitor the effectiveness of the POCRL's Quality Management System (QMS)
• Ensure that POCRL activities conform with the requirements of the laboratory QMS
• Coordinate creation, approval, implementation, and periodic reviews of Client Standard Operating Procedures for the POCRL according to GCLP guidelines
• Review and approve new assay validation plans and reports according to GCLP guidelines with reference to CAP/CLIA regulations for molecular assay validation
• Draft, review and approve continuing quality improvement documentation
• Maintain laboratory QMS documentation in Client's document management system
• Conduct annual QA audits of the POCRL & clinical trial assay processes, document findings, compose and execute Corrective and Preventative Action Plans as appropriate
• Coordinate external QA audits as required and advise laboratory director of appropriate corrective actions
• Serve as the POCRL's point of contact with clinical Biomarker Assay Specialist groups withing early- and late-clinical development
• Ensure that the maintenance/calibration status of POCRL equipment is monitored and current
TECHNICAL SKILLS:
• Ability to create and enforce laboratory standard operating procedures
• Knowledge of molecular biology and laboratory safety procedures for handling hazardous chemicals and biosafety level 2 biohazard materials
• Knowledge of standard molecular biology laboratory equipment
• Excellent written and verbal communication skills
• Ability to work independently
• Ability to interface with clinical research teams
• Proficiency with standard office software (Microsoft Office, Adobe Acrobat)
What is the minimum education experience required?:
• BS/MS in a biological science, pharmacy, medical technology, or a related field
• Medical Technology, MT (ASCP) license or equivalent (preferred)
• At least 2 years' experience working in a laboratory setting that included a QMS
• Good working knowledge of GCP/GCLP guidelines
• Experience working in a GCP/GCLP environment (preferred)