Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.
Job Overview
Manage instrumentation and technologists to ensure that laboratory results are reported accurately and in a timely manner. Maintain supply inventory and communicate operational issues to management. Perform routine testing and troubleshoot problems. Assist Laboratory management with the development of new methods, safety, and training.Performs work in accordance with ICH E6 Guideline for Good Clinical Practice.
Essential Functions
• Oversee the daily responsibilities of an assigned technical area.
• Initiate training of new staff within the technical group. Train staff Medical/Histo Technologists and Medical/Histo Laboratory Technicians and/or Assistants in proper laboratory techniques for existing and new methods. Evaluate daily performance of staff for adherence to standard operating procedures (SOPs) and efficient workflow.
• Act as primary resource for Medical/Histo Technologists and Medical/Histo Laboratory Technicians and/or Assistants in the technical area to resolve testing issues and analyzer maintenance.
• Maintain quality control of laboratory testing to ensure accurate and timely lab reporting. Document corrective and preventative actions taken using good documentation practices.
• Perform moderate/highly complex analysis of patient specimens. Evaluate validity of specimen results as per SOP guidelines. Document all corrective actions taken.
• Assist management in establishing new methodologies. Assist in completion of validation packages. Participate in selection process for new instrumentation.
• Assist management with implementing SOPs for laboratory testing and safety procedures. Implement changes in laboratory notifying all employees of necessary changes. Notify management when updates to department SOP manuals are needed to reflect procedural changes.
• Follow safety procedures as per laboratory SOPs.
• Collaborate with Project Manager with client requests and concerns. Notify management of any delays in testing and any related factors.
• Identify appropriate vendors and orders laboratory supplies as directed by management in order to maintain consistent workflow.
• Participate in continuing education through self-study, attending off-site lectures and preparing programs to share with coworkers.
Qualifications
• Bachelor's Degree or educational equivalent in Medical/Histo technology Req
• 4 years relevant experience Req Or
• Equivalent combination of education, training and experience Req
• In depth knowledge of clinical procedures used in the area of responsibility
• In depth knowledge of good laboratory practices (GLP) and other regulatory agency standards within area of responsibility
• In depth knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling
• Indepth knowledge of laboratory equipment, instrumentation and terminology used in the area of responsibility
• Effective computer skills
• Ability to maintain effective reporting procedures and control workflow
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Applicable certificaand/or other regulatory bodies by country, state, and/or other regulatory bodies Req
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