What are the responsibilities and job description for the QA RA Compliance Specialist position at ProQualityNetwork?
Job Description
Job Description
Job Opportunity : QA / RA Compliance Specialist (Biotech)
Location : Florida, USA (Open to U.S. citizens, preferably local residents)
Mode : Onsite
Positions Available : 1
Duration : Six months with possible extension
Shift : Monday to Friday, 8 : 00 AM - 5 : 00 PM or 9 : 00 AM - 6 : 00 PM
ProQuality Network is seeking a QA / RA Compliance Specialist to support one of our clients in the biotech industry. This is a contract position offering an exciting opportunity to contribute to critical quality and regulatory functions in a high-performance environment.
Key Responsibilities :
- Coordinate, track, and trend change controls issued for the facility.
- Ensure change controls meet initial requirements for implementation and review completed change controls for action completion.
- Provide initial regulatory impact assessments on change controls as required.
- Liaise with customers to satisfy regulatory and quality requirements.
- Prepare and submit regulatory documentation, including :
- A / NDA submissions (initial, amendments, supplements, annual reports, and 15-day alert reports).
- Drug master files, plant / site master files, licenses, permits, and registrations to meet FDA and state requirements (especially Florida).
- Ensure timely submission of federal, state, and local permits.
- Collect and compile data for registration activities in collaboration with customers.
- Assist in preparing and reviewing SOPs related to the regulatory function.
- Support regulatory / health authority audits by collecting and providing requested information.
- Collaborate with Subject Matter Experts (SMEs), management, and supervisors to resolve product quality issues through investigations, CAPA initiation, and resolution.
- Prepare Annual Product Reviews (APRs) in accordance with site procedures and timelines.
- Prepare complaint investigation reports, conduct root cause analysis, verify batch impact assessments, and recommend corrective actions.
- Author and review various quality system documents as assigned by QA management.
- Support site management in enforcing cGMP compliance, mentoring staff, and conducting training sessions.
- Participate in Internal Assessments, Compliance and CAPA Review Board meetings, and special projects.
Education and Experience Requirements :
Knowledge and Skills Requirements :
Ready to make a difference?
Join ProQuality Network and take the next step in your career. Apply today inside the job description with an updated resume and become part of a team dedicated to excellence!
