CSV and Lab Application Support Specialist

3 days ago

Exton, United States Frontage Laboratories Full time
CSV and Lab Application Support Specialist

Title: CSV and Lab Application Specialist

Location: Exton, PA

Reports to: Senior Director IT Infrastructure

Full-time (40 hrs./week) 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/Job Summary:

As subject matter expert (SME), the CSV and lab application specialist define and maintain Frontage lab computer system validation program and responsible for testing, implementation, validation and date to date support of software applications.

The primary responsibilities of this position will be to perform lab software/application implementation and validation, administration, data management, user support, troubleshooting cross Frontage lab to meet GxP requirements on computer systems in lab.

Roles & Responsibilities:
  • Ensure Frontage lab global computer system validation program meets both business and regulatory requirements. Assist with client and FDA audits as necessary.
  • Provide validation support for Bioanalytical, DMPK, Biologics, Clinical and IT as needed.
  • Leverage validation efforts across sites and enterprise computer system solutions as appropriate.
  • Provide support, training and guidance for validation projects.
  • Maintain a computer inventory of computer system/software
  • Maintain validated state of software through periodic reviews, change controls and review of and implementation of upgrades as needed.
  • Provide application support for lab software systems in general. Provide focused support for key systems: i.e., Watson LIMS/Sciex Analyst/QuickBase/IDBS E-WorkBook, eBinder etc.
  • Resolve user problems and provide training as necessary.
  • Evaluate and implement new software-based technologies as needed.
  • Support user account and application access control
  • Manage and interact with system vendor to escalate and resolve issues
  • Provide support, instrument qualification and software validation, enhancement, and administration of laboratory instruments and related software.
  • Support lab software application configurations related to lab instrumentations.
  • Complete documentation for the support of software changes and upgrades.
  • Drive technology improvements and efficiency opportunities to improve business and compliance.
  • Contribute to change controls and procedures specific to laboratory software.
  • Coordinate/interface/host vendors on site, when applicable.
  • Provide training in software access and functionality.
  • Ensure the software applications are validated to 21 CFR Part 1 compliance and always maintained in validated state.
  • Other duties as assigned.

Education, Experience & Skills Required:
  • Bachelor's degree in relevant scientific, engineering, or computer-based area with 5 years' experience in the pharmaceutical industry or equivalent combination of education and IT and/or lab experience.
  • Knowledge of GxP regulatory requirements, computerized analytical systems (i.e., 21 CFR part 11) and data integrity.
  • Expert in lab systems such as Watson LIMS, IDBS eNotebook,, NUGENUSIS, Waters' Empower Administration and other software programs, including Microsoft Office Applications.
  • Must have GxP experience.
  • Excellent organization, planning, and communication skills.

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.Learn More

  • CSV and Lab Application Support Specialist

    2 weeks ago

    Exton, United States Frontage Lab Full time

    CSV and Lab Application Support Specialist Title: CSV and Lab Application Specialist Location: Exton, PA Reports to: Senior Director IT Infrastructure Full-time (40 hrs./week) 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...

  • CSV and Lab Application Support Specialist

    2 weeks ago

    Exton, United States Frontage Laboratories Full time

    CSV and Lab Application Support SpecialistTitle: CSV and Lab Application SpecialistLocation: Exton, PAReports to: Senior Director IT Infrastructure Full-time (40 hrs./week) on siteFrontage 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....

  • Technical Documentation Specialist

    2 weeks ago

    Exton, Pennsylvania, United States Innovative Solutions and Support Full time

    Job OverviewWe are seeking a skilled Technical Documentation Specialist to join our team at Innovative Solutions & Support. In this role, you will be responsible for creating and maintaining high-quality documentation for various subsystem programs.

  • Warehouse Operations Specialist

    2 weeks ago

    Exton, Pennsylvania, United States Innovative Solutions and Support Full time

    Job OverviewWe are seeking a detail-oriented and organized Warehouse Operations Specialist to join our team in Exton, PA.Innovative Solutions & Support (IS&S) is a leading international avionics supplier with a strong presence in the civil, military, business, and commercial markets.Responsibilities:Inventory Management: Receive, store, issue, and move...

  • Electronics Quality Assurance Specialist

    2 weeks ago

    Exton, Pennsylvania, United States Innovative Solutions and Support Full time

    We are seeking a skilled and detail-oriented Electronics Quality Assurance Specialist to join our manufacturing team. This opportunity is on the second shift.The ideal candidate will have a strong understanding of AOI technology, excellent attention to detail, and the ability to work effectively in a fast-paced production environment.Key...

  • Project Manager Assistant-Central Laboratory

    2 weeks ago

    Exton, United States Frontage Lab Full time

    Title: Project Manager Assistant- Central Lab Location: Exton, PA Full-time 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...

  • Senior FPGA Design Engineer for Aviation Solutions

    2 weeks ago

    Exton, Pennsylvania, United States Innovative Solutions and Support Full time

    About the RoleAt Innovative Solutions & Support, Inc., we seek a talented and skilled Senior FPGA Design Engineer to join our team in Exton, PA. As a key member of our engineering staff, you will play a crucial role in designing innovative products for the aviation industry.Job SummaryWe offer a competitive salary of $90,000 - $110,000 per year, as well as...

  • Software Quality Assurance Specialist

    2 weeks ago

    Exton, Pennsylvania, United States Innovative Solutions and Support Full time

    Job SummaryAt Innovative Solutions and Support, we are seeking a Software Test Engineer to join our team. The successful candidate will be responsible for reviewing software requirements, developing test plans, and verifying the functionality of our innovative products.Key Responsibilities:Review and analyze software requirements to ensure accuracy and...

  • FPGA Development Engineer

    3 weeks ago

    Exton, United States Innovative Solutions and Support Full time

    Job DescriptionJob DescriptionInnovative Solutions & Support, Inc. seeks an engaged, curious, and skilled FPGA Development Engineer as a key addition to our Staff. Competitive salary Superior benefits packageOn-site in Exton, PAWho We AreInnovative Solutions & Support (IS&S) transforms leading edge technologies into sophisticated, cost-effective solutions...

  • PT Physical Therapist

    3 weeks ago

    Exton, United States HealthCare Support Full time

    Physical Therapist HealthCare Support is actively seeking a Physical Therapist for a 13-week contract located in Exton, Pennsylvania. Benefits of this Physical Therapistwith HealthCare Support: Immediate enrollment in Health Insurance Dental Insurance Life Insurance Employee Assistance Program (EAP) Access to open investment accounts Licensure and...

  • IT Technical Support Specialist

    1 week ago

    Exton, Pennsylvania, United States Inspiroz Full time

    Seeking a skilled IT Technical Support Specialist to join our team at Inspiroz. As a key member of our technical support team, you will provide on-site technical assistance, maintain the integrity of clients' technological infrastructure, and deliver exceptional service that improves customer satisfaction, maximizes customer retention, and increases...

  • Student Support Specialist

    1 month ago

    Exton, United States Collegium Charter School Full time

    Job Description Title: Student Support Specialist (High School) Reports To: Principal Employee Type: Full-Time, 10-months, Hourly, Non-Exempt Summary The role of the Student Support Specialist is designed to provide extended classroom support and follow up for students who have been identified as needing additional intensive support and/or students who...

  • Manufacturing Process Development Specialist

    2 weeks ago

    Exton, Pennsylvania, United States Innovative Solutions & Support Full time

    Company Overview:Innovative Solutions & Support (IS&S) is a dynamic organization committed to delivering innovative solutions and exceptional support to its clients. Our team of experts is dedicated to helping businesses succeed in their respective fields, and we are seeking a highly skilled Manufacturing Process Development Specialist to join our team.Job...

  • Aviation Systems Certification Specialist

    2 weeks ago

    Exton, Pennsylvania, United States Innovative Solutions and Support Full time

    Job OverviewInnovative Solutions and Support (IS&S) is a leading provider of analog and digital instrumentation to the military, commercial, and business sectors within the aviation marketplace. We offer technological solutions to major aircraft manufacturers and operators worldwide.The development of new products has led to exceptional career opportunities...

  • Avionics Assembly Specialist

    7 days ago

    Exton, Pennsylvania, United States Innovative Solutions & Support Full time

    Electronics Assembly Role at Innovative Solutions & SupportWe are seeking an experienced Electronics Assembly Specialist to join our team at Innovative Solutions & Support. In this role, you will be responsible for assembling and integrating components for avionics systems using shop paperwork, engineering blueprints, and manual/powered hand tools.The ideal...

  • Loan Servicing Support Specialist

    7 days ago

    Exton, United States Citadel Federal Credit Union Full time

    Job OverviewIs this your next job Read the full description below to find out, and do not hesitate to make an application.This position is primarily a support role in the Consumer Loan Division. This position will require the individual to work closely with the Indirect Audit Processing Funders and the Loan Servicing Representatives.Duties and...

  • Loan Servicing Support Specialist

    2 weeks ago

    Exton, United States Citadel Federal Credit Union Full time

    Job OverviewIs this your next job Read the full description below to find out, and do not hesitate to make an application.This position is primarily a support role in the Consumer Loan Division. This position will require the individual to work closely with the Indirect Audit Processing Funders and the Loan Servicing Representatives.Duties and...

  • Student Support Specialist

    1 month ago

    Exton, United States Collegium Charter School Full time

    Position Type: Support Staff/Student Support Specialist Date Posted: 10/30/2024 Location: Collegium Charter School Date Available: Immediately Job Description Title: Student Support Specialist (High School) Reports To: Principal Employee Type: Full-Time, 10-months, Hourly, Non-Exempt Summary The role of the Student Support Specialist is designed to provide...

  • Design Support Specialist

    2 weeks ago

    Exton, Pennsylvania, United States NextGen Security Full time

    About the RoleWe are seeking an experienced Design Support Specialist to join our dynamic team at NextGen Security LLC.Job SummaryThis is a hybrid role supporting both the CAD Department and the Pre-Sales Design Department.In this role, you will work closely with the CAD Manager, System Designers, Account Managers, and Project Managers to create high-quality...

  • Behavioral Support Specialist for Exton, PA School

    2 weeks ago

    Exton, Pennsylvania, United States ProCare Therapy Full time

    Job OverviewWe are seeking a dedicated Behavioral Support Specialist to join our team in Exton, PA.Salary and BenefitsThe salary for this role is estimated to be around $45,000 - $60,000 per year, with benefits available for positions 30 hours a week and over.Job ResponsibilitiesProvide 1:1 or group support to studentsRecord data and implement behavior...