Specialist Manufacturing
mîrus Consulting Group Ver todas las vacantes
- Juncos, PR
- Permanente
- Tiempo completo
The Manufacturing Specialist is responsible for supporting day‑to‑day manufacturing operations in a GMP‑regulated environment. This role ensures manufacturing processes are executed in compliance with established procedures, regulatory requirements, and quality standards. The Manufacturing Specialist plays a key role in deviation documentation, change control execution, and continuous improvement initiatives while supporting operational efficiency and compliance.Key Responsibilities
- Support daily manufacturing operations within a pharmaceutical GMP environment, ensuring adherence to batch records, standard operating procedures (SOPs), and safety requirements.
- Lead and support deviation documentation, investigation, and resolution in alignment with site procedures and quality standards.
- Manage and execute Change Control activities, including assessment, documentation, impact analysis, and implementation.
- Collaborate cross‑functionally with Quality, Engineering, Validation, and Supply Chain to resolve operational issues and support process improvements.
- Participate in continuous improvement initiatives to enhance process efficiency, compliance, and operational robustness.
- Support audits and regulatory inspections by providing documentation, data, and subject matter expertise.
Candidates must meet one of the following education and experience requirements:
- Doctorate degree OR
- Master’s degree plus 2 years of Manufacturing Operations experience OR
- Bachelor’s degree plus 4 years of Manufacturing Operations experience