Pre-Analytical Laboratory Manager

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The Manager, Pre-Analytical Laboratory will oversee the operations of Prevention Genetics' Pre-Analytical department, including Accessioning the Extraction Lab, and Genetic Testing Coordinators to ensure scalability and consistent quality of pre-analytical laboratory operations. This individual will ensure all pre-analytical systems are functioning properly to consistently achieve turnaround time targets. The Manager, Pre-Analytical Laboratory will also conduct all quality-related activities as specified in the Quality Management System and be sure the department meets regulatory compliance and service quality.

This individual will lead the Pre-Analytical department through projects and improvement activities that contribute directly to Prevention Genetics key results, ensuring budgets, project schedules and business requirements are met.

The Manager, Pre-Analytical Laboratory will serve as a liaison between Pre-Analytics and various functional groups; including, but not limited to, customer service, the Analytical laboratory, Post-Analytical Department, process and service engineering, information technology, human resources, quality, supply chain management and workplace services to report and address immediate issues or concerns. The Manager will also participate in cross-functional teams that improve the infrastructure, workflow and processes throughout our Clinical Laboratory to accommodate rapidly growing assay volumes, an expanding test menu, introduction of new technologies and business models, expansion to multiple laboratory sites, and continuous changes in the external regulatory landscape.

This individual will consult with Quality and provide guidance to the Accessioning and Extraction Lab teams to address non-conformances, complaints and CAPAs within the Pre-Analytical department at Prevention Genetics.

• Manage the operations of the Pre-Analytical 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.
• Collaborate with the Accessioning Associate Supervisor, the Extraction Lab Associate Supervisor and the GTC Supervisor on tasks including but not limited to recruitment, goal setting, professional development, mentoring, training and competency assessment, performance assessments and compliance.
• Lead and maintain the engagement of staff and project team members, practicing above-the-line communication to create a culture of accountability, and encouraging activities to foster team building.
• Collaborate with other functional groups to capture and analyze actionable data, to identify and implement new processes and practices, based on evidence, for continuous improvements and to achieve performance targets.
• Ensure consistent compliance with all applicable federal, state, local and international regulatory requirements and with all company policies and procedures.
• Complies with safety protocols.
• Under the guidance of Quality, provide guidance to the Pre-Analytical department 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.
• 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.
• Lead or participate in Pre-Analytical process improvement activities 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. The activities include, but are not limited to, staff training, review of checklists and formulate responses, internal audits of documents and records, and mock inspections. Support discussions with the inspectors on department operational topics and ensure that any deficiencies or findings are addressed efficiently within the specified timeline.
• Participate in developing, modifying, and executing company policies that affect immediate pre-analytical laboratory operations and may also have…