Sr Specialist QA - 35713

Mirus Consulting Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

mîrus Consulting Group is seeking a Sr Specialist QA to provide quality oversight for validation, qualification, and quality system activities in a regulated pharma manufacturing environment.

You will review protocols, reports and change controls, support CSV for GxP systems, and lead risk assessments to drive continuous improvement and regulatory readiness across facilities and processes.

Qualifications

• Advanced degree with direct QA/validation experience in regulated environments.
• Experience with lifecycle validation in GMP settings.
• Strong understanding of data integrity and GDP requirements.

Responsibilities

• Provide QA oversight for validation, qualification and commissioning activities.
• Review and approve qualification documentation to ensure compliance.
• Support CSV activities for GxP systems and risk assessments.
• Lead change controls and ensure GDP and data integrity compliance.
• Participate in audits, regulatory readiness and cross-functional collaboration.

Skills

Quality Assurance

Regulatory knowledge

Risk assessment

Cross-functional collaboration

Audits & regulatory readiness

Education

Doctorate degree in a related field

Master’s degree in related field

Bachelor’s degree in related field

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

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 oversight and support for validation, commissioning, qualification, and quality system activities within a regulated pharmaceutical manufacturing environment. This role ensures compliance with internal procedures, current GMP regulations, data integrity standards, and corporate quality requirements. The Senior Specialist QA will collaborate cross-functionally to review, approve, and support qualification and validation lifecycle activities while driving quality risk management and continuous improvement initiatives.

Key Responsibilities

• Provide Quality Assurance oversight for Facilities, Utilities, Equipment Commissioning, Qualification, and Validation activities.
• Review and approve commissioning, qualification, validation, and lifecycle documentation to ensure compliance with regulatory and company requirements.
• Support and oversee Computer System Validation (CSV) activities for GxP systems.
• Review and approve protocols, reports, discrepancy investigations, and validation deliverables.
• Lead and participate in Risk Assessments and risk management activities to support quality and compliance decisions.
• Support the administration, review, and approval of Change Controls associated with facilities, utilities, equipment, systems, and processes.
• Ensure compliance with Good Documentation Practices (GDP) and Data Integrity requirements.
• Review, revise, and approve quality and validation documentation including Standard Operating Procedures (SOPs).
• Provide quality support for Syringe and Vial Inspection Processes, ensuring adherence to established quality standards.
• Utilize electronic quality and validation systems including KNEAT, CDOCS, SCADA, TrackWise, and Maximo.
• Participate in audits, inspections, and regulatory readiness activities.
• Apply sound decision-making methodologies to resolve quality-related issues and support operational excellence.
• Collaborate with Manufacturing, Engineering, Validation, and Quality organizations to ensure successful project execution.
• Identify opportunities for process improvements while maintaining compliance with GMP and quality requirements.

Minimum 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.