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CSV and Lab Application Support Specialist

0fad767f F389 40ea B2d1 D8df05098476 19000101 000001 · Exton, PA, US, Exton, PA · On Site · Active · ADP Workforce Now Recruiting

Job facts

FieldValue
Company0fad767f F389 40ea B2d1 D8df05098476 19000101 000001
TitleCSV and Lab Application Support Specialist
Normalized title-
Department / team-
LocationExton, PA, United States
Work modelOn Site
Employment typeFull Time
Salary-
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2024-07-30 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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PageWhat it containsOpen
Company jobsActive postings from 0fad767f F389 40ea B2d1 D8df05098476 19000101 000001.Open
Company breakdownsRole, location, ATS, and work model facets for this company.Open
ATS provider jobsActive postings observed through ADP Workforce Now Recruiting.Open
Provider filtered searchThe same provider as a filtered job collection.Open
City jobsActive postings in Exton.Open
Work model jobsActive On Site postings.Open
Lifecycle eventsOpen, update, close, and reopen events for this posting.Open
Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

Company0fad767f F389 40ea B2d1 D8df05098476 19000101 000001
Source57b990c1-73e8-474a-b966-75ea19495511
ATS providerADP Workforce Now Recruiting

Description

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.

Full job record

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Org IDb9d3aab9-695d-4b2b-bd3f-ae58acddd87a
Source ID57b990c1-73e8-474a-b966-75ea19495511
Board ID57b990c1-73e8-474a-b966-75ea19495511
Provideradp_workforcenow
Provider Job Key488279
TitleCSV and Lab Application Support Specialist
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Statusactive
Activeyes
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Department—
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Employment Typefull_time
Workplace Typeon_site
Remote Policy—
CountryUnited States
RegionPA
CityExton
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First Seen At2026-05-31 18:30:14Z
Last Seen At2026-06-06 20:27:00Z
Last Checked At2026-06-06 20:27:00Z
Last Changed At2026-06-06 20:27:00Z
Inactive At—
Source Posted At2024-07-30 18:32:00Z
Source Updated At—
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line-height: 107%; font-family: arial, sans-serif;\">CSV and Lab Application Support Specialist</span></strong></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><strong><span style=\"line-height: 107%;\">Title:</span></strong></span><span style=\"font-size: 16px; line-height: 107%; font-family: arial, sans-serif;\">&nbsp;CSV and Lab Application Specialist</span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><strong><span style=\"line-height: 107%;\">Location:</span></strong></span><span style=\"font-size: 16px; line-height: 107%; font-family: arial, sans-serif;\">&nbsp;Exton, PA</span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><strong><span style=\"line-height: 107%;\">Reports to</span></strong></span><span style=\"font-size: 16px; line-height: 107%; font-family: arial, sans-serif;\">:&nbsp; Senior Director IT Infrastructure&nbsp;</span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><strong><span style=\"line-height: 107%;\">Full-time (40 hrs./week) on site</span></strong></span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><br></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;' id=\"isPasted\"><span style=\"font-size: 16px; font-family: arial, sans-serif; color: black;\">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. &nbsp;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.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><br></span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><strong><u><span style=\"line-height: 107%;\">Position/Job Summary:</span></u></strong></span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-size: 16px; line-height: 107%; font-family: arial, sans-serif;\">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.</span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-size: 16px; line-height: 107%; font-family: arial, sans-serif;\">&nbsp;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.</span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><br></span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><strong><u><span style=\"line-height: 107%;\">Roles &amp; Responsibilities:</span></u></strong></span></p><ul style=\"list-style-type: disc;margin-left: -0.25in;\"><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Ensure Frontage lab global computer system validation program meets both business and regulatory requirements. Assist with client and FDA audits as necessary.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Provide validation support for Bioanalytical, DMPK, Biologics, Clinical and IT as needed.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Leverage validation efforts across sites and enterprise computer system solutions as appropriate.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Provide support, training and guidance for validation projects.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Maintain a computer inventory of computer system/software</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Maintain validated state of software through periodic reviews, change controls and review of and implementation of upgrades as needed.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">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.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Resolve user problems and provide training as necessary.&nbsp;</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Evaluate and implement new software-based technologies as needed.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Support user account and application access control</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Manage and interact with system vendor to escalate and resolve issues</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Provide support, instrument qualification and software validation, enhancement, and administration of laboratory instruments and related software.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Support lab software application configurations related to lab instrumentations.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Complete documentation for the support of software changes and upgrades.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Drive technology improvements and efficiency opportunities to improve business and compliance.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Contribute to change controls and procedures specific to laboratory software.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Coordinate/interface/host vendors on site, when applicable.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Provide training in software access and functionality.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Ensure the software applications are validated to 21 CFR Part 1 compliance and always maintained in validated state.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Other duties as assigned.</span></li></ul><p><span style=\"line-height: 107%; font-family: arial, sans-serif; font-size: 16px;\"><br></span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><strong><u><span style=\"line-height: 107%;\">Education, Experience &amp; Skills Required:</span></u></strong></span></p><ul style=\"list-style-type: disc;margin-left: -0.25in;\"><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Bachelor&#39;s degree in relevant scientific, engineering, or computer-based area with 5 years&#39; experience in the pharmaceutical industry or equivalent combination of education and IT and/or lab experience.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Knowledge of GxP regulatory requirements, computerized analytical systems (i.e., 21 CFR part 11) and data integrity.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Expert in lab systems such as Watson LIMS, IDBS eNotebook,, NUGENUSIS, Waters&rsquo; Empower Administration and other software programs, including Microsoft Office Applications.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Must have GxP experience.</span></li><li style=\"font-family: arial, sans-serif; font-size: 16px;\"><span style=\"line-height: 107%;\">Excellent organization, planning, and communication skills.</span></li></ul><p><span style=\"line-height: 107%; font-family: arial, sans-serif; font-size: 16px;\"><br></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;' id=\"isPasted\"><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><strong><u><span style=\"color: rgb(51, 51, 51);\">Salary and Benefits</span></u></strong><strong><span style=\"color: rgb(51, 51, 51);\">:</span></strong></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:12.05pt;background:white;'><span style=\"font-size: 16px; font-family: arial, sans-serif; color: rgb(65, 65, 65);\">Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.</span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-size: 16px; line-height: 107%; font-family: arial, sans-serif;\">&nbsp;</span></p><p style='margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\"><em><span style=\"line-height: 107%;\">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.</span></em></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 16px;\">&nbsp;</span></p></div></div></div></div></div></div>\n",
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    "requisitionTitle": "CSV and Lab Application Support Specialist",
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