Frontage Lab

Laboratory Info System Application Specialist

Exton, PA, US

Remote
Full-time
10 days ago
Save Job

Summary

Laboratory Info System Application Specialist Location: Exton PA Full-time, On-site Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary: The Laboratory Information System (LIS) Application Specialist will be responsible for implementation and maintenance of the Central Laboratory Information System, instrument middleware, and other supporting software systems for Central Lab Services. Responsibilities: * Build and maintain LIS/LIMS database for clinical trial and medical diagnostic testing and Biorepository * Assist laboratory management and QA Specialist with comprehensive Change Control related to the Laboratory Information Systems. * Liaise between laboratory management, QA, and Information Technology departments, coordinating multidisciplinary efforts * Partner with Study Setup and Project Management to build appropriate tests and calculations * Working with Senior System Administrator to develop and maintain Central Lab Service procedures regarding LIS/LIMS, middleware, and other supporting software systems * Ensure HIPAA and GDPR compliance in Central Lab Services processes in conjunction with QA and laboratory management. Requirements: * B.A/B.S. in Biology, chemistry, or related scientific disciplines with experience in a clinical laboratory setting * Minimum of 1 years' experience in test build * Experience with LabVantage * Experience in performing or assisting clinical laboratory testing * Working knowledge of FDA GCP, CLIA Regulations, HIPAA, CAP checklists are highly desirable * High level of accountability with self and others * Hands-on approach with a desire to teach others * Track record of challenging the status quo * Team and action-oriented * Problem-solving * Priority setting * Timely decisions Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability

How strong is your resume?

Upload your resume and get feedback from our expert to help land this job