QA/RA Compliance Specialist (3465590)

Contract Opportunity: QA/RA Compliance Specialist (3465590)

Location: Pinellas Park, FL (Open to local residents who are U.S. citizens)

Positions Available: 2

Work Schedule: Monday – Friday | 8:00 a.m. – 5:00 p.m. or 9:00 a.m. – 6:00 p.m.

Duration: Approximately 6 months, with possible extension

Work Arrangement: 100% Onsite

Summary:

Our client, a leading organization in the regulated pharmaceutical manufacturing industry, is seeking two (2) QA/RA Compliance Specialists for a contract opportunity. The selected professionals will play a key role in supporting Quality Assurance and Regulatory Affairs functions, ensuring compliance with FDA, state, and corporate requirements. This role involves managing change controls, regulatory submissions, complaint investigations, and supporting internal and external audits.

Key Responsibilities:

• Coordinate, track, and trend Change Controls to ensure all required actions are properly implemented and closed on time.
• Perform initial regulatory impact assessments on change controls and collaborate with responsible teams to ensure compliance.
• Liaise directly with customers to ensure all regulatory and quality requirements are met.
• Prepare and submit the following documentation as required:
• ANDA/NDA submissions (initial, amendments, supplements, annual reports, and 15-day alert reports)
• Drug Master Files (initial, amendments, and annual reports)
• Site/Plant Master Files, licenses, permits, and registrations in compliance with FDA and Florida state regulations.
• Ensure timely submission of federal, state, and local permits and maintain records accordingly.
• Collaborate with customers to gather data and documentation in support of product registrations.
• Assist in the preparation, review, and approval of Standard Operating Procedures (SOPs) related to QA and RA functions.
• Support regulatory and health authority audits, providing requested information promptly and accurately.
• Collaborate with Subject Matter Experts (SMEs) and management teams to resolve quality issues, including CAPA initiation and follow-up to closure.
• Prepare Annual Product Reviews (APRs) in compliance with site procedures and regulatory timelines.
• Conduct and document complaint investigations, ensuring appropriate root cause analysis, impact assessment, and implementation of corrective/preventive actions.
• May author or revise other Quality System documents as assigned by QA management.
• Participate in internal assessments, CAPA Review Boards, and compliance meetings, ensuring timely follow-up and closure of action items.
• Provide support in enforcing cGMP compliance, mentoring junior staff, and assisting in training activities.
• Perform additional responsibilities or special projects as assigned to support department and site objectives.

Education and Experience Requirements:

• Bachelor’s degree in Science or a related field (Chemistry, Microbiology, or Biology preferred).
• Minimum of 3 years of related experience in the pharmaceutical manufacturing industry.
• Strong background in Change Control management and process improvement.
• Proven experience in investigation writing, root cause analysis, and report preparation.
• Experience preparing Annual Product Reviews (APRs) preferred.
• PathWise Certification is a plus.

Knowledge, Skills, and Competencies:

• Prior Regulatory Affairs, Quality Assurance, or Quality Control experience required.
• Strong working knowledge of U.S. application regulations, cGMPs, and FDA guidance.
• Excellent organizational and time management skills with strong attention to detail.
• Effective oral and written communication skills; capable of drafting clear and compliant documentation.
• Highly motivated self-starter with the ability to work independently and collaboratively.
• Strong multitasking and problem-solving abilities with a customer-service mindset.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Access).
• Knowledge of OSHA regulations and general safety compliance preferred.
• Demonstrated commitment to quality, teamwork, and continuous improvement.

If you are an experienced Quality or Regulatory professional seeking your next opportunity within a respected and dynamic pharmaceutical environment, we invite you to apply through the job description link with your updated resume for immediate consideration.