Specialist QA - 35807

Mirus Consulting Group; Puerto Rico; Vor Ort; USD 70.000 - 100.000; Vollzeit

Zusammenfassung

mîrus Consulting Group in Humacao, Puerto Rico seeks a Specialist QA to provide quality assurance support for GMP manufacturing, ensuring compliance with regulatory requirements and company procedures.

The role collaborates with Manufacturing, Engineering and Process Development to resolve quality issues, maintain data integrity, and drive continuous improvement.

Qualifikationen

• Review and approve quality system documents including Change Controls, Deviations, CAPAs, protocols, reports, and SOPs.
• Ensure compliance with cGMP, GDP, and regulatory requirements.
• Provide Quality Assurance oversight for packaging and inspection operations.
• Assist during internal audits, regulatory inspections and quality assessments.

Aufgaben

• Review, evaluate, and approve quality system documentation.
• Collaborate with Manufacturing, Engineering and Process Development to resolve issues.
• Support the implementation and maintenance of electronic quality systems.

Kenntnisse

Quality Assurance

cGMP knowledge

GDP knowledge

Data integrity

Root cause analysis

Cross-functional collaboration

Bilingual English/Spanish

Ausbildung

Doctorate Degree

Master's Degree

Bachelor's Degree

Jobbeschreibung

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

• 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
  

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.