Laboratory Information System Specialist

3 days ago


Exton, Pennsylvania, United States Frontage Laboratories Full time
Job Title: Laboratory Information System Application Specialist

Frontage Laboratories Inc. is a leading Contract Research Organization (CRO) 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.

Job Summary:

The Laboratory Information System (LIS) Application Specialist will be responsible for implementing and maintaining the Central Laboratory Information System, instrument middleware, and other supporting software systems for Central Lab Services.

Key Responsibilities:

  • Design and maintain LIS/LIMS database for clinical trial and medical diagnostic testing and Biorepository
  • Collaborate with laboratory management and QA Specialist on comprehensive Change Control related to the Laboratory Information Systems
  • Facilitate communication between laboratory management, QA, and Information Technology departments, coordinating multidisciplinary efforts
  • Partner with Study Setup and Project Management to build appropriate tests and calculations
  • Work 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 year's 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

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.



  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job SummaryFrontage Laboratories Inc. is seeking a skilled Laboratory Information System (LIS) Application Specialist to join our team. As a key member of our Central Lab Services team, you will be responsible for implementing and maintaining the Central Laboratory Information System, instrument middleware, and other supporting software systems.Key...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job DescriptionJob Title: Clinical Laboratory Information System SpecialistJob Summary:Frontage Laboratories is seeking a highly skilled Clinical Laboratory Information System Specialist to join our team. As a Clinical Laboratory Information System Specialist, you will be responsible for implementing and maintaining the Central Laboratory Information System,...


  • Exton, Pennsylvania, United States System One Full time

    {"Overview": "System One is seeking a highly skilled Quality Assurance Specialist to contribute to the success of our pharmaceutical company's operation. The ideal candidate will have a strong background in biological or chemical sciences and experience in cGMP Quality Control, analytical development, and validation departments in a FDA-regulated industry.",...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job SummaryWe are seeking a highly skilled Medical Laboratory Specialist to join our team at Frontage Laboratories. As a key member of our Central Lab Services, you will be responsible for ensuring the accuracy and reliability of laboratory results.Key ResponsibilitiesInstrumentation and Method Validation: Validate and verify new instrumentation and methods...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job DescriptionJob Summary:The Laboratory Vendor Management Specialist plays a critical role in ensuring the quality, efficiency, and compliance of laboratory vendors for Phase 1, 2, and 3 clinical trials at Frontage Laboratories Inc.Key Responsibilities:Vendor Selection and Onboarding:Evaluate and select laboratory vendors based on quality, cost, and...

  • Laboratory Scientist

    1 month ago


    Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job SummaryWe are seeking a highly skilled Medical Laboratory Specialist to join our team at Frontage Laboratories. As a key member of our Central Lab Services, you will be responsible for ensuring the accuracy and reliability of laboratory results.Key ResponsibilitiesInstrumentation and Method Validation: Validate and verify new instrumentation and methods...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job SummaryWe are seeking a highly skilled Medical Laboratory Specialist to join our team at Frontage Laboratories. As a key member of our Central Lab Services, you will be responsible for ensuring the smooth operation of our laboratory facilities.Key ResponsibilitiesInstrumentation Management: Validate and verify new instrumentation and methods, establish...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Clinical Laboratory Services Job Summary At Frontage Laboratories, we are seeking a highly skilled Medical Technologist to join our team in Exton, PA. As a Medical Technologist, you will play a critical role in building and maintaining our Central Lab Services. Responsibilities: * Perform validation and verification studies of new instrumentation and...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Summary:The Medical Technologist will be responsible for day-to-day activities in building and maintaining Central Lab Services at Frontage Laboratories.Key Responsibilities:Validation and verification studies of new instrumentation and methodsEstablish and maintain standard operating procedures for designated methodsPerform maintenance and quality...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job SummaryFrontage Laboratories is seeking a Medical Technologist to join our team in Exton, PA. As a Medical Technologist, you will be responsible for performing a variety of laboratory tests and procedures to ensure the accuracy and reliability of test results.Key Responsibilities:Perform validation and verification studies of new instrumentation and...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Title: Team Leader, Computer System Validation and Application SupportJob Summary:We are seeking a highly skilled and experienced Team Leader, Computer System Validation and Application Support to join our team at Frontage Laboratories Inc. As a key member of our validation team, you will be responsible for defining and maintaining our computer system...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job SummaryFrontage Laboratories Inc. is a leading contract research organization operating over 25 state-of-the-art laboratories across the US, Canada, and China. We are seeking a Medical Technologist to join our Central Lab Services team in Exton, PA.The successful candidate will be responsible for day-to-day activities in building and maintaining Central...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Title: Specimen ProcessorJoin Frontage Laboratories, a leading Contract Research Organization, as a Specimen Processor in our Central Laboratory Services team. We are seeking a highly motivated and detail-oriented individual to support our laboratory operations.Responsibilities:Accurately accession, sort, and store laboratory specimensProcess specimens,...


  • Exton, Pennsylvania, United States JobsRUs Full time

    Job Title: Laboratory TechnicianWe are seeking a highly skilled Laboratory Technician to join our team at JobsRUs. As a Laboratory Technician, you will be responsible for conducting laboratory tests and inspections on raw materials, in-process, and finished products.Key Responsibilities:Conduct laboratory tests and inspections on raw materials, in-process,...

  • Laboratory Technician

    2 weeks ago


    Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Title: Laboratory TechnicianWe are seeking a highly skilled Laboratory Technician to join our team at Frontage Laboratories Inc. Our company is an award-winning, publicly listed Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China.Job Summary:The successful candidate will perform and support...


  • Exton, Pennsylvania, United States System One Holdings, LLC Full time

    Job Title:Quality Analyst 2Job Summary:We are seeking a highly skilled Quality Analyst 2 to join our team at System One Holdings, LLC. The successful candidate will be responsible for providing accurate and GxP-compliant analyses of clinical biopharmaceutical products, participating in assay qualification and validation studies, and maintaining laboratory...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Title: Laboratory TechnicianWe are seeking a highly skilled Laboratory Technician to join our team at Frontage Laboratories Inc. Our company is a leading Contract Research Organization (CRO) operating over 25 state-of-the-art laboratories across the US, Canada, and China.The successful candidate will be responsible for performing and supporting...


  • Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Title: CSV and Lab Application Support SpecialistFrontage Laboratories Inc. is a leading Contract Research Organization (CRO) operating over 25 state-of-the-art laboratories across the US, Canada, and China. We are seeking a highly skilled CSV and Lab Application Support Specialist to join our team.Job Summary:The CSV and Lab Application Support...


  • Exton, Pennsylvania, United States System One Holdings, LLC Full time

    Job Title:Quality Analyst 2Job Summary:System One Holdings, LLC is seeking a Quality Analyst 2 to contribute to the success of our pharmaceutical company by providing accurate, GxP-compliant analyses of clinical biopharmaceutical products and participating in assay qualification and validation studies.Responsibilities:Conduct quality control testing of...

  • QC Specialist

    4 days ago


    Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Title: Quality Control Specialist - Large MoleculeAt Frontage Laboratories, we are seeking a highly skilled Quality Control Specialist - Large Molecule to join our team. As a key member of our quality control department, you will be responsible for ensuring the accuracy, consistency, and completeness of biologics bioanalytical data.Key...