职位描述
职位描述: PURPOSEPerform a variety of testing procedures of moderate to high complexity to obtain data for use in clinical trials research.RESPONSIBILITIES? Perform a variety of testing procedures of moderate to high complexity. Evaluate validity of specimen results as per standard operating procedure (SOP) guidelines. Document all corrective actions taken.? Provide oversight and guidance to Medical/Histo Laboratory Technicians and/or Assistants. Assist with training of new staff within the assigned group. Train staff Medical Technologists and Medical/Histo Laboratory Technicians and/or Assistants in proper laboratory techniques for existing and new methods.? Maintain quality control of laboratory testing to ensure accurate and timely lab reporting. Document corrective and preventative actions taken using good documentation practices.? Assist management in establishing new methodologies. Assist in completion of validation packages.? 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.All responsibilities are essential job functions unless noted as nonessential (N).REQUIRED KNOWLEDGE, SKILLS AND ABILITIES? Good knowledge of clinical procedures used in the area of responsibility? Knowledge of Good Clinical Laboratory Practices (GCLP) and other regulatory agency standards within area of responsibility? Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling? Knowledge of laboratory equipment, instrumentation and terminology used in the area of responsibility? Basic computer skills? Ability to maintain effective reporting procedures and control workflow? Ability to establish and maintain effective working relationships with coworkers, managers and clientsMINIMUM REQUIRED EDUCATION AND EXPERIENCE? Bachelor’s degree or educational equivalent in medical/histo technology and 2 years relevant experience or equivalent combination of education, training and experience? Applicable certifications and licenses as required by country, state, and/or other regulatory bodiesPHYSICAL REQUIREMENTS? Work is performed in a laboratory e***ironment, full manual dexterity and visual acuity required? May be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools and equipment 职能类别: 生物工程/生物制药 医药学检验
公司信息
Q2 Solutions is a global clinical trials laboratory services organization formed as part of a joint venture transaction between QuintilesIMS and Quest Diagnostics. It comprises Quintiles’ former Global Central Laboratories, BioAnalytical/ADME and genomics businesses and Quest Diagnostics’ former clinical trials business.
Q2 Solutions was born out of a shared commitment to quality, customer service and – above all – helping bring new treatments to patients. Q2 Solutions helps biopharma, medical device, and diagnostic customers improve human health through innovation that transforms science and data into actionable medical insights.
Q2 Solutions is committed to providing our customers an innovative, progressive and responsive partner with the quality focus, global experience and deep medical expertise integral to drug, medical device, and diagnostic development. - See more at: http://www.q2labsolutions.com/about-us#sthash.TKFpb15K.dpuf