The Fountain Group
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:
Quality Assurance Specialist – R&D Quality Agreements (GMP/GDP Focus) Location:
Onsite – Lake County, IL Pay Rate:
$41-$44/hour
Role Overview 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
Qualifications
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
Quality Assurance Specialist – R&D GCP Focus Location:
Onsite – Lake County, IL Pay Rate:
$41-$44/hour
Role Overview 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)
Qualifications
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)
#J-18808-Ljbffr
QA Specialists
for a prominent client of ours. This position is in
North Chicago, IL 60064 . Details for the position are as follows:
Quality Assurance Specialist – R&D Quality Agreements (GMP/GDP Focus) Location:
Onsite – Lake County, IL Pay Rate:
$41-$44/hour
Role Overview 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
Qualifications
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
Quality Assurance Specialist – R&D GCP Focus Location:
Onsite – Lake County, IL Pay Rate:
$41-$44/hour
Role Overview 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)
Qualifications
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)
#J-18808-Ljbffr