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Specialist Manufacturing - 35922
mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Summary
The Manufacturing Specialist is responsible for providing technical support and leadership to manufacturing operations, ensuring compliance with quality standards, regulatory requirements, and operational excellence initiatives. This role supports manufacturing processes through deviation management, CAPAs, change control activities, risk assessments, and documentation management while driving continuous improvement and operational efficiency.
Key Responsibilities
One of the following combinations is required:
Position Summary
The Manufacturing Specialist is responsible for providing technical support and leadership to manufacturing operations, ensuring compliance with quality standards, regulatory requirements, and operational excellence initiatives. This role supports manufacturing processes through deviation management, CAPAs, change control activities, risk assessments, and documentation management while driving continuous improvement and operational efficiency.
Key Responsibilities
- Support daily manufacturing operations to ensure safe, compliant, and efficient production processes.
- Lead and support investigations related to manufacturing deviations, non-conformances, and process excursions.
- Author, review, and manage Corrective and Preventive Actions (CAPAs) and Change Controls (CC).
- Perform and document Risk Assessments to evaluate manufacturing processes, product quality, and compliance risks.
- Serve as a CDOC Editor, ensuring accurate preparation, review, and maintenance of controlled manufacturing documentation.
- Collaborate with cross-functional teams including Quality Assurance, Quality Control, Engineering, Validation, Supply Chain, and Operations.
- Monitor manufacturing metrics and recommend process improvements to enhance productivity, compliance, and product quality.
- Ensure all activities comply with GMP regulations, site procedures, and applicable regulatory requirements.
- Support audits, inspections, and regulatory commitments as required.
- Participate in continuous improvement initiatives and operational excellence projects.
One of the following combinations is required:
- Doctorate degree; OR
- Master’s degree and 3 years of Manufacturing Operations experience; OR
- Bachelor’s degree and 5 years of Manufacturing Operations experience.