Frontage Laboratories, Inc · 1 week ago
QA Specialist-GLP/BIO
Exton, PA, US
Full-time
Onsite
Mid LevelFrontage Laboratories Inc. is an award-winning, full-service CRO operating over 25 state-of-the-art laboratories. The Quality Assurance Specialist is responsible for conducting QA audits of BIO laboratories, reporting quality issues, and maintaining audit records to ensure compliance with GLP regulations.
BiotechnologyClinical TrialsMedicalPharmaceuticalRobotics
Responsibilities
The QA Specialist conducts QA audits of BIO laboratories and functions including but not limited to ongoing process, data review audits, technical report, and study independent facility / process
The QA specialists reports quality issues to QA management, Study Director and laboratory management as appropriate
QA Specialist will maintain audit detailed notes, reports and records on Frontage Systems
Review, support and maintain Standard Operating Procedures
Provide oversight and input to investigations and CAPA as appropriate
Support and train staff on GLP regulations and SOPs as needed
Qualification
Required
Working knowledge of US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, and other relevant guidance and publications
BS/BA in a relevant scientific discipline experience may substitute for minimum education requirement
Experience in quality systems and quality assurance processes, development and documentation
Preferred
Experience in Bio-Analytical Laboratory preferred
Benefits
Health and dental insurance
A 401(k) plan
Disability insurance
Life insurance
Company
Frontage Laboratories, Inc
Frontage Laboratories is a US-based Contract Research Organization (CRO) that was initially established in New Jersey in April 2001 and later relocated to Pennsylvania in 2004.
Founded in 2001
1001-5000 employees
H1B Sponsorship
Frontage Laboratories, Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (38)
2024 (37)
2023 (24)
2022 (29)
2021 (34)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$42.37MKey Investors
Baird Capital
2019-05-30IPO
2018-03-01Undisclosed· $32.37M
2014-05-08Acquired
Leadership Team
Song Li
CEO
Abdul Mutlib
Vice President
Recent News
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