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. 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.