QA RA Compliance Specialist
Manpower Group (USA), St. Petersburg, FL, United States
Our client,
a leading pharmaceutical manufacturing organization , is seeking a
Regulatory Affairs / Quality Specialist
to join their team. As a
Regulatory Affairs / Quality Specialist , you will be part of the
Quality Assurance / Regulatory Affairs Department , supporting site operations, regulatory compliance, and cross‑functional teams. The ideal candidate will have
strong attention to detail ,
excellent organizational skills , and
a proactive, collaborative mindset , which will align successfully within the organization.
Job Title: Regulatory Affairs / Quality Specialist
Location: Onsite position (Monday–Friday, 8:00 AM – 5:00 PM or 9:00 AM – 6:00 PM)
Pay Range: $30.00 per hour
What’s the Job?
Coordinate, track, and trend Change Controls, including regulatory impact assessments and closure verification
Prepare and submit regulatory documents and filings (A/NDA submissions, amendments, DMFs, permits, licenses, and reports) per FDA and State requirements
Collaborate with customers, subject matter experts, and internal teams to support compliance, investigations, and CAPA initiatives
Support regulatory and health authority audits, SOP development, and internal assessments
Prepare APRs, complaint investigations, and quality system documentation ensuring timely and compliant completion
What’s Needed?
Bachelor’s Degree in Science or related field (Chemistry, Microbiology, Biology)
Minimum of 3 years of experience in pharmaceutical manufacturing, quality, or regulatory affairs
Strong experience with Change Control management, investigations, and root cause analysis
Working knowledge of cGMPs, FDA regulations, and U.S. application requirements
Excellent communication, organizational, and multi‑tasking skills with high attention to detail
What’s in it for me?
Competitive pay at $30/hour
Six‑month assignment with possible extension
Consistent Monday–Friday schedule with daytime hours
Opportunity to work in a highly regulated, quality‑driven environment
Professional growth within a globally recognized pharmaceutical organization
#J-18808-Ljbffr
a leading pharmaceutical manufacturing organization , is seeking a
Regulatory Affairs / Quality Specialist
to join their team. As a
Regulatory Affairs / Quality Specialist , you will be part of the
Quality Assurance / Regulatory Affairs Department , supporting site operations, regulatory compliance, and cross‑functional teams. The ideal candidate will have
strong attention to detail ,
excellent organizational skills , and
a proactive, collaborative mindset , which will align successfully within the organization.
Job Title: Regulatory Affairs / Quality Specialist
Location: Onsite position (Monday–Friday, 8:00 AM – 5:00 PM or 9:00 AM – 6:00 PM)
Pay Range: $30.00 per hour
What’s the Job?
Coordinate, track, and trend Change Controls, including regulatory impact assessments and closure verification
Prepare and submit regulatory documents and filings (A/NDA submissions, amendments, DMFs, permits, licenses, and reports) per FDA and State requirements
Collaborate with customers, subject matter experts, and internal teams to support compliance, investigations, and CAPA initiatives
Support regulatory and health authority audits, SOP development, and internal assessments
Prepare APRs, complaint investigations, and quality system documentation ensuring timely and compliant completion
What’s Needed?
Bachelor’s Degree in Science or related field (Chemistry, Microbiology, Biology)
Minimum of 3 years of experience in pharmaceutical manufacturing, quality, or regulatory affairs
Strong experience with Change Control management, investigations, and root cause analysis
Working knowledge of cGMPs, FDA regulations, and U.S. application requirements
Excellent communication, organizational, and multi‑tasking skills with high attention to detail
What’s in it for me?
Competitive pay at $30/hour
Six‑month assignment with possible extension
Consistent Monday–Friday schedule with daytime hours
Opportunity to work in a highly regulated, quality‑driven environment
Professional growth within a globally recognized pharmaceutical organization
#J-18808-Ljbffr