POSITION TITLE: TECHNICAN - GxP
DEPARTMENT: Cincinnati Children's Hospital Medical Center
SUPERVISOR'S TITLE: Translational Core Laboratory Manager or Director
TITLES SUPERVISED: NA
TOTAL NUMBER OF FTEs DIRECTLY OR INDIRECTLY SUPERVISED: 0
PURPOSE OF POSITION: Independently perform dayto-day Translational Core Laboratory assignments, make accurate observations, and analyze data. Perform all regulated activities strictly according to SOP with accurate documentation. Perform manufacturing processes, equipment/instrumentation maintenance, facilities upkeep, and laboratory procedures that are essential to the GxP production and analysis of biomedical products or CAP/CLIA requirements for high complexity analysis. Cooperate with Quality Assurance group from the Office of Research Compliance and Regulatory Affairs to ensure the quality of product, test results and compliance.
Assist in training laboratory personnel. May act as a mentor to more junior staff. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. May provide input and feedback to managers on hiring decisions, professional development and performance management.
·Compliance and Continuous Improvement:
Follow Standard Operating Procedures (SOP) and protocols. Cooperate with performance improvement initiatives and other compliance activities. Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance. Perform assigned duties strictly according to SOP. Maintain required proficiency and competency requirements.
·Perform methods and record data:
Perform manufacturing/processing activities, process development, quality control, and high complexity analysis as directed following established SOPs and protocols. Complete accurate and detailed records and all documentation as required for compliance to GxP. Complete and maintain training required to perform assigned tasks. Maintain cell cultures. Design and execute daily laboratory work. Analyze data, perform statistical and graphical analysis of data, and interpret results. Understand the scientific principles involved in the research and work being performed and apply those principles to improve techniques as appropriate. Maintain an active role in laboratory's meetings, presentations, and publications. Contributes material for reports, publications, journal articles, and abstracts.
·Facility and Equipment:
Perform day-to-day translational core laboratory operations including cleanroom facilities maintenance and equipment maintenance plus fee-for-service support as assigned. Operate standard laboratory equipment according to protocol. Promptly respond to and troubleshoot erroneous results or problems with laboratory equipment or facilities. Order supplies from vendors and storeroom and ensure proper storage requirements are met. Report facility and equipment failure and alarms to laboratory management or QA team.
Perform work with a high level of integrity and honesty. Practice a high level of integrity in maintaining confidentiality. Maintain required documentation systems. Willing and able to assist in daily operations of the laboratory including answering phone, organizing and cleaning of laboratory. Provides appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.) Perform other duties as assigned.
Skills & Competencies
Effective verbal and interpersonal communication skills. Capable of understanding and following verbal and written instructions.
Ability to relate to diverse age and demographic backgrounds.
Demonstrate high clerical accuracy, attention to detail, strong organizational skills, and an independent work initiative. Computer literate and working knowledge of software applications (word processing, spreadsheet, and database). Computer literate and working knowledge of software applications (word processing, spreadsheet, and database).
Analytical ability sufficient to compare data; mathematical ability sufficient to perform algebraic calculations and statistical analysis.
Ability to operate laboratory equipment. Knowledge of scientific terminology and ability to analyze data and compose reports. Able to identify mistakes and discuss resolution plan. Attention to the veracity of results. Capable of meeting time demands necessary to execute requirements.
Position is subject to occasional long, irregular hours with changing priorities; must be able to work under deadline pressure which may require a flexible work schedule. Must be a Team Player
·Bachelor's degree in related discipline AND one year experience working full time as a Research Assistant II OR equivalent combination of similar post graduate professional experience an undergraduate experience in an extensive internship that is 1) In a designated and nationally recognized research environment 2) Evidenced by contributions to the peer-reviewed literature. OR
·Master's Degree in a related discipline
·Experience with laboratory techniques including instrumentation, quantitative skills, tissue culture, or aseptic techniques Preferred:
·Previous experience working in a similar regulated environment such as GTP, GMP, GLP or GCP is a plus