Under minimal supervision from the Operations Director, this position oversees general lab operations. When required, performs all operations, and provides general support to all departments. Directly reports to the director of operations with oversight form laboratory director and the quality assurance team.
• Ensure new employee training and cross-training is in compliance with all lab rules, regulations, standard work, standard operating procedures and associated guidelines.
• In conjunction with the Scientific Director, assures that all methods and validations meet with certification and compliance requirements.
• Develops and implements approved work processes including SOPs, standard work, TWI, and other methodologies.
• Acts as the lab’s change agent, implementing improvements and streamlined processes.
• Acts as the IT contact for lab issues, system upgrades and new machine installation. Provides technical support for software testing.
• Actively participates in all internal inspections. Technical resource and participant for external audits and inspections.
• Develops, leads, and assures programs are meeting company standards.
• Documents discrepancies, exceptions, and unusual trends. Researches and rectifies errors.
• Works with Lab Director and staff to develop, draft and implement corrective action plans.
• Assists analysts with exception items, answers questions and generally assists less experienced employees.
• Follows all laboratory policies and procedures; adheres to all health and safety standards
• Determines proper levels of materials and makes sure inventory is maintained to meet anticipated volumes. Performs or oversees validation processes for materials from new suppliers, assuring optimum levels of performance.
• Prepares monthly packets and tracking reports. Analyzes machine and personnel trends and makes recommendations for improvements/changes.
• Analyzes, recommends, and implements worker and work area standardizations, methods, processes, and procedures.
• Provides support for team leads, assuring that personnel levels are appropriate for continuous workflow while maintaining first pass-through quality.
• Prepares justification for increased manpower requirements.
• Oversees all chain of custody (CoC) processes, and validates compliance.
• Performs or reviews audits of processes, work production, employee knowledge and competency and documents results.
• Schedules staff to assure optimum production and work coverage.
• Responsible to maintain operational all safe guards as it pertains to Protected health information (PHI)
• Promptly report concerns to all appropriate laboratory leadership and/or staff for effective feedback loop, quality improvement and training
Education and Experience:
• Education and Experience: Must have Bachelor’s Degree in a hard science (Chemistry preferred) and 4 or more years managing experience.
• New York State Clinical Laboratory Technician (CLT) certificate highly desirable
• Background check and pre-employment drug screen required.
• Experience leading a successful production team.
Knowledge, Skills, and Abilities:
• Must be competent in basic toxicology lab processes
• Able to develop and interpret technical documentation for training and end user procedures
• Strong troubleshooting and problem-solving skills, able to work well with all team members
• Understand and carry out instructions, reason and make judgments; perform arithmetic operations quickly and accurately
• Extensive practical knowledge in importing data for use in report software, spreadsheets, graphs, and flowcharts.
• Good analytical and problem-solving abilities.
• Strong work ethic, detail oriented, punctual, organized, personable, reliable, and dependable
• High motivation level, personal integrity and accountability, strong communication skills
• Ability to effectively prioritize and execute tasks in a high-pressure environment