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Pre-Analytical Director
Ref No.: 19-00639
Category: Biotechnology
Location: San Diego, California

Responsibilities:
  • Manage the operations of the Accessioning department including but not limited to the following: anticipating, planning for, and acquiring the required staffing, equipment, space, and workflow improvements for pre-analytical laboratory operations
  • Monitoring quality assurance performance metrics
  • Planning, validation and implementation of new process procedures or equipment
  • Leading and supervision of personnel
  • Managing resources, project timelines and deliverables
  • Lead the Accessioning team through subordinate management staff and with direct management responsibilities including but not limited to recruitment, goal setting, professional development, mentoring, training and competency assessment, performance assessments and compliance
  • Collaborate with other functional groups to capture and analyze actionable data, to identify, design and implement new processes and practices, based on evidence, for continuous improvements and to achieve performance targets
  • Ensure the consistency of information from test order forms and labels on patient samples, and ensure the timeliness, accuracy, and appropriate documentation of all quality-related activities specified in the Quality Management System
  • Ensure consistent compliance with all applicable federal, state, local and international regulatory requirements and with all company policies and procedures
  • Under the guidance of Quality, provide guidance to Accessioning and support personnel to ensure timely and effective investigation, documentation, corrective action, and preventive action associated with nonconformance, complaints, and CAPAs occurring within the Clinical Laboratory Lead cross-functional teams through improvement events with support from Engineering, Quality and other functional teams.
  • Ensure that implementation of improvements run smoothly and that gains are sustained Contribute to inspection preparation efforts with Quality and various support teams.
  • Ensure that business objectives are met within the timeline defined
  • Establish operational objectives and assignments and delegates assignments to subordinates.
  • Review objectives with senior management to determine success of operation Participate in developing, modifying and executing company policies that affect immediate pre-analytical laboratory operations and may also have company-wide effect
  • Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and immediately communicating these to the appropriate management representatives as necessary to ensure prompt resolution
  • Other responsibilities as assigned

QUALIFICATIONS:
  • 7-10 years of related experience in a Diagnostic Reference Lab.
  • Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related fields
  • At least five years of management experience with a proven track record of implementing changes, scaling operations for growth, staff development, and building successful teams
  • Track record of leading process or quality improvement projects, allocating resources and prioritizing key deliverables to optimize delivery timelines while meeting all critical requirements
  • Knowledge of Microsoft Word, Excel, PowerPoint, Visio, Project, Outlook, quality and document control systems
  • Knowledge of local, state, federal and international laboratory regulations, international standards for quality management systems
  • Experiences in a Clinical Laboratory setting involving moderate or high-complexity laboratory tests