Specialist QA - 35807

Mirus Consulting Group

🇵🇷 Puerto Rico
1 day ago

1 day ago

Not enough detail in this posting to match

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
TheSpecialist 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, includingChange 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.
ProvideQuality Assurance oversight and support forpackaging 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.

Specialist QA - 35807 · Mirus Consulting Group

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