Quality Assurance; QA
Listed on 2026-01-14
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Quality Assurance - QA/QC
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Healthcare
Data Scientist, Medical Science
The Fountain Group is a national staffing firm, and we are currently seeking two QA Specialists for a prominent client of ours. This position is in North Chicago, IL 60064
. Details for the position are as follows:
Location: Onsite – Lake County, IL
Pay Rate: $41-$44/hour
This role supports Research & Development with a primary focus on Quality Agreements across GMP/GDP-regulated activities. The position partners cross-functionally to ensure compliance, drive process improvements, and support global regulatory expectations.
Key Responsibilities- Support and improve the R&D Quality Agreement process
, including periodic review and maintenance - Lead or participate in complex, cross-functional quality initiatives
- Drive or support strategic initiatives to enhance regulatory compliance
- Proactively identify and implement process improvements
, including SOP and procedure updates - Balance hands‑on involvement with independent, objective quality oversight
- Collect, analyze, and report quality metrics to assess effectiveness and inform decisions
- Bachelor’s degree preferred (Physical Science, Life Science, Pharmacy, Engineering, Business, or related)
- 5–7 years of experience in Quality Assurance or Regulatory Affairs (pharma or medical device preferred)
- 3–5 years experience in manufacturing, clinical R&D, or investigational product analysis
- 7+ years total combined experience
- Strong experience with Quality Agreements and global regulatory requirements (GMP/GDP)
- Excellent written and verbal communication skills; confident cross‑functional partner
- Working knowledge of GMP
, SOPs, and quality systems
Location: Onsite – Lake County, IL
Pay Rate: $41-$44/hour
This role serves as a GCP subject matter expert within R&D, with a strategic emphasis on early detection, prevention, and correction of compliance issues across clinical programs and external partners.
Key Responsibilities- Act as an R&D quality expert for Good Clinical Practice (GCP) requirements
- Collaborate with GCP functional teams to resolve external partner quality issues
- Lead or support GCP-focused strategic initiatives to strengthen compliance
- Participate in technically complex, cross-function quality projects
- Drive process improvements
, including review and update of supporting procedures - Support Clinical Quality Agreement development and periodic review (as needed)
- Bachelor’s degree in a scientific or technical field (Chemistry, Biology, Pharmacy, Microbiology, Engineering) 8+ years equivalent industry experience
- Thorough understanding of international GCP regulations and standards
- Strong technical background with deep knowledge of global quality system requirements
- Excellent communication, judgment, and stakeholder‑management skills
- Ability to influence and work effectively across internal teams and external partners
- Professional certification preferred (ASQ CQM, CQA, RQAP, or similar)
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