The Fountain Group · 7 hours ago
Quality Assurance (QA) Specialist III
North Chicago, IL
Contract
Onsite
Senior Level, Lead/Staff
$41/hr - $44/hr
8+ years expThe Fountain Group is a national staffing firm currently seeking a Clinical Quality Assurance (GCP) Specialist for a prominent client. This role focuses on supporting R&D activities with an emphasis on Good Clinical Practice compliance and involves collaboration with internal teams and external vendors to ensure adherence to regulatory standards.
ConsultingRecruitingStaffing Agency
Responsibilities
Serve as a GCP subject matter expert within R&D, with a strategic focus on early detection, prevention, and correction of quality issues
Collaborate with internal GCP functional areas to resolve quality issues related to external partners, CROs, and suppliers
Lead or participate in technically complex, cross-functional GCP projects, including strategic quality initiatives
Support GCP-focused compliance initiatives to improve alignment with global regulatory requirements and industry standards
Drive process improvements, including review and updates to supporting processes, SOPs, and procedures
Balance hands-on involvement with independence and objectivity while maintaining strong stakeholder partnerships
Support the creation, review, and periodic maintenance of Clinical Quality Agreements (CQAs) with clinical vendors, as applicable
Demonstrate strong collaboration, leadership, and a continuous improvement mindset while fostering a learning-oriented environment
Qualification
Required
Bachelor's degree in a scientific or technical discipline (e.g., Chemistry, Pharmacy, Biology, Microbiology, Engineering) OR equivalent industry experience (minimum 8 years) within pharmaceutical, medical device, or combination product environments
Strong, hands-on GCP experience (non-negotiable)
Thorough understanding of international GCP regulatory standards
Technical background with extensive knowledge of global quality systems requirements
Excellent oral and written communication skills, with the ability to influence and collaborate across functions and external partners
Demonstrated project management experience within a Clinical QA or GCP environment
Strong organizational skills, sound judgment, independence, and ability to operate as a self-starter
Solid understanding of Good Documentation Practices (GDP)
Preferred
Experience supporting or managing Clinical Quality Agreements (CQAs) with clinical vendors (CROs, labs, service providers)
Familiarity with GCP vendor agreements and supplier oversight models
Exposure to Avoca and/or TransCelerate CQA templates
Professional certifications such as: ASQ Certified Quality Manager (CQM), Registered Quality Assurance Professional (RQAP), Certified Quality Auditor (CQA)
Company
The Fountain Group
The Fountain Group is a staffing firm that specializes in rendering contingent workforce solutions to various industries.
501-1000 employees
H1B Sponsorship
The Fountain Group 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
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Trends of Total Sponsorships
2025 (52)
2024 (34)
2023 (21)
2022 (42)
2021 (41)
2020 (14)
Funding
Current Stage
Late StageLeadership Team
Jahnavi Patel
Finance Business Partner
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