QA Specialist – GMP & Quality Systems Expert

Mirus Consulting Group; Juncos (PR); On-site; USD 60,000 - 85,000; Full time

Job summary

mîrus Consulting Group based in Puerto Rico seeks a Specialist QA to support GMP manufacturing operations, ensuring compliance with regulatory requirements and company procedures. You will collaborate with Manufacturing, Engineering and Process Development to resolve quality issues and maintain product quality throughout the process.

The role involves reviewing quality system documentation, participating in internal audits, and supporting electronic quality systems while promoting state of

Qualifications

• Doctorate, Master's, or Bachelor's degree with directly related experience.
• Bilingual in English and Spanish preferred.
• Strong analytical, problem-solving, and organizational skills.

Responsibilities

• Review, evaluate, and approve quality system documentation (Change Controls, Deviations, CAPAs, protocols, reports, SOPs).
• Ensure compliance with cGMP, GDP, and regulatory requirements.
• Provide QA oversight for packaging and inspection operations.
• Assess investigations and CAPAs to identify root causes and implement effective solutions.
• Participate in cross-functional teams to support manufacturing and process improvements.
• Support electronic quality systems and related documentation.
• Review and approve manufacturing, validation, and operation records for data integrity and compliance.
• Collaborate with departments to resolve quality issues and drive continuous improvement.
• Assist during internal audits, regulatory inspections, and quality assessments.
• Identify compliance risks and maintain inspection readiness.
• Bilingual proficiency in English and Spanish preferred.
• Exhibit strong organizational, analytical, and problem-solving skills.

Skills

Bilingual English/Spanish

Analytical thinking

Problem-solving

Quality-minded

Education

Doctorate degree

Master's degree

Bachelor's degree

Job description

mîrus Consulting Group based in Puerto Rico seeks a Specialist QA to support GMP manufacturing operations, ensuring compliance with regulatory requirements and company procedures. You will collaborate with Manufacturing, Engineering and Process Development to resolve quality issues and maintain product quality throughout the process.

The role involves reviewing quality system documentation, participating in internal audits, and supporting electronic quality systems while promoting state of