QA/RA Compliance Specialist (3465590)

ProQuality Network; Florida; Sur place; USD 60 000 - 90 000; Plein temps

Résumé du poste

ProQuality Network is seeking two QA/RA Compliance Specialists for a 6-month contract in Pinellas Park, FL. Onsite role supporting FDA/state requirements, change controls, regulatory submissions, and audits.

Candidates should have a science degree, 3+ years in pharma manufacturing, and strong Change Control experience. PathWise cert is a plus; role involves SOPs, CAPA, APRs, and collaboration with SMEs.

Qualifications

• Bachelor's degree in Science or related field (Chemistry, Microbiology, 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.

Responsabilités

• Coordinate, track, and trend Change Controls to ensure actions are implemented and closed on time.
• Perform regulatory impact assessments on change controls and ensure compliance.
• Liaise with customers to ensure regulatory and quality requirements are met.
• Prepare and submit regulatory documents (ANDA/NDA submissions; Drug Master Files; site licenses and registrations).
• Ensure timely submission of federal, state, and local permits and maintain records.
• Assist in the preparation, review, and approval of SOPs related to QA and RA functions.
• Support regulatory and health authority audits and document requests.
• Collaborate with SMEs and management to resolve quality issues and drive CAPA closure.
• Prepare Annual Product Reviews (APRs) in compliance with site procedures.

Connaissances

Regulatory Affairs

Quality Assurance

cGMP

Oral communication

Written communication

Attention to detail

Time management

Problem solving

Formation

Bachelor's degree in Science

Outils

Microsoft Office Suite

Description du poste

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.