QA RA Compliance Specialist

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

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.