Sr Specialist QA - 35712

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 Sr Specialist QA is responsible for providing Quality Assurance oversight and support for commissioning, qualification, validation, and quality systems activities within a regulated manufacturing environment. This role ensures compliance with GMP regulations, internal procedures, and quality standards while supporting equipment validation, Change Controls, SOP management, risk assessments, and documentation review and approval processes. The incumbent will work cross-functionally with Engineering, Manufacturing, Validation, and Quality teams to ensure operational excellence, inspection readiness, and continuous improvement initiatives.

Key Responsibilities
Quality Assurance Support

• Provide QA oversight for commissioning, qualification, and validation activities associated with manufacturing equipment, utilities, facilities, and systems.
• Review and approve validation lifecycle documentation to ensure compliance with regulatory requirements and site procedures.
• Support quality initiatives and continuous improvement projects to maintain a state of compliance.
• Participate in regulatory inspections and internal audits as required.

Commissioning, Qualification & Validation

• Review and approve commissioning and qualification documentation, including protocols, reports, and supporting records.
• Provide quality support for equipment validation activities and lifecycle management.
• Ensure validation activities comply with approved procedures, regulatory requirements, and industry standards.
• Collaborate with Validation, Engineering, and Operations teams to resolve quality-related issues.

Quality Systems

• Support and manage Change Control activities, ensuring proper assessment, documentation, implementation, and closure.
• Review investigations, deviations, and corrective actions to ensure timely and compliant resolution.
• Assess quality risks and participate in Quality Risk Assessments (QRAES) to support business and compliance decisions.
• Ensure quality records are complete, accurate, and ready for inspection.

Documentation Management

• Review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications, and other GMP documents.
• Ensure compliance with Good Documentation Practices (GDP) and data integrity requirements.
• Support document revisions, document control processes, and implementation of quality system updates.
• Maintain documentation in electronic quality systems, including Kneat and other validated platforms.

Qualifications

• Doctorate degree and 2 years of directly related experience; OR
• Master’s degree and 4 years of directly related experience; OR
• Bachelor’s degree and 6 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.