Contract Opportunity: QA/RA Compliance Specialist (3465590)
Location: Pinellas Park, FL (Open to local residents who are U.S. citizens)
Positions Available: 2Work 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 seekingtwo (2) QA/RA Compliance Specialistsfor 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 Controlsto ensure all required actions are properly implemented and closed on time.
- Perform initialregulatory impact assessmentson change controls and collaborate with responsible teams to ensure compliance.
- Liaise directly withcustomersto 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 offederal, state, and local permitsand maintain records accordingly.
- Collaborate with customers to gather data and documentation in support of product registrations.
- Assist in thepreparation, review, and approval of Standard Operating Procedures (SOPs)related to QA and RA functions.
- Supportregulatory 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 documentcomplaint investigations, ensuring appropriate root cause analysis, impact assessment, and implementation of corrective/preventive actions.
- May author or revise other
- Quality System documentsas 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 degreein Science or a related field (Chemistry, Microbiology, or Biology preferred).Minimum of 3 yearsof related experience in thepharmaceutical manufacturing industry .Strong background inChange Control managementand process improvement. Proven experience ininvestigation writing, root cause analysis, and report preparation. Experience preparing Annual Product Reviews (APRs)preferred. PathWise Certificationis a plus.
Knowledge, Skills, and Competencies:
PriorRegulatory Affairs, Quality Assurance, or Quality Controlexperience required.
Strong working knowledge ofU.S. application regulations, cGMPs, andFDA guidance .Excellent organizational and time management skills with strong attention to detail.
Effectiveoral and written communicationskills; capable of drafting clear and compliant documentation.
Highlymotivated self-starterwith the ability to work independently and collaboratively.
Strongmultitasking and problem-solvingabilities with a customer-service mindset.
Proficient inMicrosoft Office Suite(Word, Excel, PowerPoint, Access).Knowledge ofOSHA regulationsand general safety compliance preferred.
Demonstrated commitment to quality, teamwork, and continuous improvement.
