Cincinnati Children's Hospital Medical Center - Research Careers

Research Jobs
at Cincinnati Children's Hospital Medical Center

Full Job Title: Translational Labs - Specialist GxP

Job Number: 92602

Location: Cincinnati, OH

Date Posted: 5-12-2017

POSITION TITLE: SPECIALIST - GxP

DEPARTMENT: Cincinnati Children's Hospital Medical Center

SUPERVISOR'S TITLE: Translational Core Laboratory Manager or Director

TITLES SUPERVISED: NA

TOTAL NUMBER OF FTE's INDIRECTLY SUPERVISED: 1-2

PURPOSE OF POSITION: Independently perform assigned tasks including development, technology transfer, scale up, manufacturing/processing and analysis are performed according to schedule. Perform qualifications and validations to support manufacturing processes, equipment/instrumentation, facilities, laboratory methodology and quality assurance procedures that are essential to the GxP production and analysis of biomedical products or CAP/CLIA requirements for high complexity analysis. Make accurate observations, analyze data and assist others. Ensure regulated activities are performed strictly according to SOP with accurate documentation. Cooperate with Quality Assurance group from the Office of Research Compliance and Regulatory Affairs to ensure the quality of product, test results and compliance.

Responsibilities
·Leadership:
Train laboratory personnel on proper laboratory and compliance techniques. 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:
Create, modify and follow Standard Operating Procedures (SOP) and Protocols. Cooperate with performance improvement initiatives and other compliance activities. Interact with QA to coordinate manufacturing, processing and testing activities (i.e. production suite cleaning schedule, release of the production suite, issuance of batch record, etc.). Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance. Perform assigned duties strictly according to SOP. Maintain optimal protocol and assay accuracy by conducting regular quality and reproducibility checks. Maintain required proficiency and competency requirements.
·Design and perform methods and record data:
Perform manufacturing/rocessing activities, process development, technology transfer, scale up, 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. Participate in the development of new assays and testing of new protocols. Modify and adapt new procedures as requested. Analyze data, perform statistical and graphical analysis of data, and interpret results. Provide qualification and validation support for manufacturing processes, equipment/instrumentation, facilities, laboratory methodology and quality assurance procedures that are essential to the GxP production and analysis of biomedical products or CAP/CLIA requirements for high complexity analysis. Maintain an active role in the laboratory's meetings, presentations, and publications. Present information on research and laboratory work to others at laboratory meetings, journal clubs, and seminars.
·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. Maintain and repair equipment; monitor proper use by personnel. 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. Maintain stocks of chemicals and solutions. Report facility and equipment failure and alarms to laboratory management or QA team. Wear issued pager, or other communication devices, and respond to all emergency calls promptly for critical equipment failure.
·Lab Administration:
Perform work with a high level of integrity and honesty. Practice a high level of integrity in maintaining confidentiality. Maintain required documentation systems. Provide Material Safety Data Sheet (MSDS) training according to regulations. Communicate with external vendors to obtain technical information as needed. Assists in daily operations of the laboratory including answering phone, maintaining lab supplies, organization, and cleanliness. Provide written and oral reports to management on a regular basis. Provide appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.) Perform other duties as assigned.

Skills & Competencies
·Interpersonal Communication
Effective verbal and interpersonal communication skills. Capable of understanding and following verbal and written instructions.
·Diversity
Ability to relate to diverse age and demographic backgrounds.
·Work Initiative
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).
·Mathematics
Analytical ability sufficient to compare data; mathematical ability sufficient to perform algebraic calculations and statistical analysis.
·Professional Knowledge
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.
·Team Player
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

Required:
·Bachelor's degree in related discipline
·Three years of total experience, including two years as a Translational Core Technician OR equivalent relevant experience which includes laboratory procedures, instrumentation, animal handling, high complexity assays, training in compliance issues, training in compliance issues, training in a specialized technical/analytical modality and teaching
·Master's Degree OR two years of experience including one year as a Translational Core Technician OR

Preferred:
·Master's degree OR equivalent post Bachelor's degree in a related discipline
·Previous experience working in a similar regulated environment such as GTP, GMP, GLP or GCP is a plus

Cincinnati Children’s is an Equal Opportunity Employer. Qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, age, genetic information, physical or mental disability, military or veteran status, sexual orientation, gender identity/expression, or other protected status in accordance with applicable federal, state, and local laws and regulations. If you would like more information about equal employment opportunity (EEO) rights as an applicant under the law, please click here

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