Project Manager - Remediation
Flexible & Integrated Technical Services
- Dorado, PR
- Permanente
- Tiempo completo
- Bachelor’s Degree in Engineering or Science and three (3) years of experience in quality assurance or systems in the regulated industry.
- Bilingual: Spanish and English
- Soft Skills: Attention to detail, organization, and writing skills.
- Shift: Administrative and according to business
- Experience:
- Project Management - Quality remediation activities.
- Rework qualification, document revision, & CAPA.
- Risk assessments, document change management, and compliance improvements.
- Electronic quality management systems (eQMS)
- FDA, GMP & ISO regulations.
- Oversee and coordinate product and process rework projects ensuring compliance with approved protocols and regulatory requirements.
- Manage the review and revision of controlled documents (e.g., SOPs, work instructions, protocols, batch records) as part of remediation project deliverables, ensuring timely completion and stakeholder approval.
- Lead impact assessments and risk analysis initiatives for nonconformances and historical deviations, coordinating resources and timelines to meet project objectives.
- Ensure project changes are documented and tracked appropriately, maintaining traceability, justification, and alignment with quality standards throughout the project lifecycle.
- Coordinate and facilitate cross-functional team collaboration (Engineering, QA, Manufacturing) to gather required technical inputs, manage dependencies, and resolve project bottlenecks.
- Oversee root cause investigation projects and manage the implementation of corrective and preventive actions (CAPAs), including resource allocation, timeline management, and progress tracking.
- Maintain comprehensive project documentation of all remediation activities, manage project schedules, ensure milestone completion, and provide regular status updates to stakeholders and leadership.