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Specialist Manufacturing - 35529
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 Specialist Manufacturing will support manufacturing operations through the effective management of deviations, investigations, and related quality systems processes. This role is responsible for leading and owning manufacturing investigations, conducting deviation assessments, identifying root causes, and ensuring timely closure of records while maintaining compliance with regulatory and company requirements.
Key Responsibilities
Candidates must meet one of the following combinations of education and experience:
Position Summary
The Specialist Manufacturing will support manufacturing operations through the effective management of deviations, investigations, and related quality systems processes. This role is responsible for leading and owning manufacturing investigations, conducting deviation assessments, identifying root causes, and ensuring timely closure of records while maintaining compliance with regulatory and company requirements.
Key Responsibilities
- Lead and own manufacturing investigations related to process, equipment, and operational deviations.
- Perform thorough deviation assessments and impact evaluations to determine product, process, and compliance risks.
- Identify and document root causes using structured investigation methodologies and root cause analysis tools.
- Develop, recommend, and track corrective and preventive actions (CAPAs) to ensure effective issue resolution.
- Manage and maintain deviation records in TrackWise or equivalent quality management systems.
- Collaborate cross-functionally with Manufacturing, Engineering, Quality, Technical Services, and other departments to support investigation activities.
- Ensure investigations are completed accurately, thoroughly, and within established timelines.
- Support continuous improvement initiatives by analyzing deviation trends and identifying opportunities for process enhancements.
- Assist during audits and inspections by providing investigation documentation and supporting records.
- Ensure compliance with cGMP regulations, company procedures, and industry standards.
Candidates must meet one of the following combinations of education and experience:
- Doctorate Degree OR
- Master's Degree and 2 years of Manufacturing Operations experience OR
- Bachelor's Degree and 4 years of Manufacturing Operations experience
- Bachelor's Degree in Engineering or a related technical discipline.
- Experience in biotechnology, biopharmaceutical, pharmaceutical, or regulated manufacturing environments.
- Proven experience as an owner of manufacturing investigations and deviation management processes.
- Strong knowledge of root cause analysis methodologies and investigation tools.
- Experience using TrackWise or similar electronic quality management systems.
- Experience handling customer complaints and complaint investigations.
- Knowledge of cGMP regulations and manufacturing operations.
- Strong analytical, problem-solving, organizational, and technical writing skills.
- Ability to manage multiple priorities and work effectively in a fast-paced environment.
- Excellent communication and cross-functional collaboration skills.