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Specialist QA - 35807
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 QA is responsible for providing Quality Assurance support to GMP manufacturing operations, ensuring compliance with regulatory requirements, quality standards, and company procedures. This role partners closely with Manufacturing, Engineering, Process Development, and other functional areas to support quality systems, resolve quality issues, and maintain product quality throughout the manufacturing process.
Key Responsibilities
Qualifications
Position Summary
The Specialist QA is responsible for providing Quality Assurance support to GMP manufacturing operations, ensuring compliance with regulatory requirements, quality standards, and company procedures. This role partners closely with Manufacturing, Engineering, Process Development, and other functional areas to support quality systems, resolve quality issues, and maintain product quality throughout the manufacturing process.
Key Responsibilities
- Review, evaluate, and approve quality system documentation, including Change Controls, Deviations, CAPAs, protocols, reports, and Standard Operating Procedures (SOPs).
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
- Provide Quality Assurance oversight and support for packaging and inspection operations.
- Assess investigations and corrective/preventive actions to ensure root causes are identified and effective solutions are implemented.
- Participate in cross-functional teams to support manufacturing processes, process improvements, and project initiatives.
- Support the implementation and maintenance of electronic quality systems and related documentation.
- Review and approve manufacturing, validation, and operational records to ensure data integrity and compliance.
- Collaborate with Manufacturing, Engineering, Process Development, and other departments to resolve quality-related issues and drive continuous improvement.
- Assist during internal audits, regulatory inspections, and quality assessments.
- Identify compliance risks and recommend actions to maintain a state of inspection readiness.
- Bilingual proficiency in English and Spanish preferred.
- Excellent organizational, analytical, and problem-solving skills.
Qualifications
- Doctorate Degree OR
- Master's Degree and 2 years of directly related experience OR
- Bachelor's Degree and 4 years of directly related experience