Specialist Manufacturing - 35787

Mirus Consulting Group; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico, seeks a Specialist Manufacturing to serve as External Supply Quality Record Owner, leading supplier-related Change Control records to ensure compliance, quality, and timely execution.

You will drive cross-functional collaboration with Quality, Manufacturing, Regulatory, and suppliers, manage Change Control activities using TrackWise and SAP, and maintain GMP compliance throughout the records lifecycle.

Qualifications

• Doctorate Degree with relevant manufacturing operations exposure is preferred.
• Master’s Degree plus 2 years of Manufacturing Operations experience.
• Bachelor’s Degree plus 4 years of Manufacturing Operations experience.

Responsibilities

• Serve as External Supply Quality Record Owner, responsible for managing and executing supplier-related Change Control quality records with minimal supervision.
• Manage and execute Change Control activities associated with external suppliers, ensuring documentation, impact assessments, approvals, and timely closures.
• Lead cross-functional meetings with Quality, Manufacturing, Supply Chain, Regulatory, Engineering, and External Supply stakeholders to drive progress and resolve issues.
• Assess supplier-related quality records using risk-based decision-making to ensure compliance and product quality.
• Monitor Change Control timelines, identify risks, escalate issues, and drive actions to meet deadlines.
• Coordinate the implementation of supplier changes and ensure alignment with internal procedures and regulatory requirements.
• Utilize TrackWise and SAP systems to manage quality records, documentation, workflows, and related activities.
• Ensure accurate and compliant documentation of Change Controls, actions, approvals, and supporting records.
• Collaborate with internal and external stakeholders to facilitate effective communication and execution of quality-related initiatives.
• Support audits, inspections, and quality reviews by providing documentation and Change Control records as required.
• Analyze trends, identify process improvement opportunities, and recommend solutions to enhance quality system effectiveness.
• Maintain compliance with GMP, company policies, and applicable regulatory requirements.

Skills

Change Control processes

Quality systems

Supplier quality management

Cross-functional collaboration

Education

Doctorate Degree

Master’s Degree and 2 years of Manufacturing Operations experience

Bachelor’s Degree and 4 years of Manufacturing Operations experience

Tools

TrackWise

SAP

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 Specialist Manufacturing is responsible for serving as the External Supply Quality Record Owner, leading and managing supplier-related Change Control quality records to ensure compliance, quality, and timely execution. This role requires strong expertise in Change Control processes, quality systems, supplier quality management, and cross-functional collaboration. The incumbent will drive the progression and closure of quality records, facilitate stakeholder alignment, and ensure compliance with applicable regulatory and company standards while working with minimal supervision.

Key Responsibilities

• Serve as External Supply Quality Record Owner, responsible for managing and executing supplier-related Change Control quality records with minimal supervision.
• Manage and execute Change Control activities associated with external suppliers, ensuring accurate documentation, impact assessments, approvals, and timely closure.
• Lead cross-functional meetings with Quality, Manufacturing, Supply Chain, Regulatory, Engineering, and External Supply stakeholders to drive progress and resolve issues.
• Assess supplier-related quality records using critical thinking and risk-based decision-making to ensure compliance and product quality.
• Monitor Change Control timelines, identify risks, escalated issues when necessary, and drive actions to meet established deadlines.
• Coordinate the implementation of supplier changes and ensure alignment with internal procedures, regulatory requirements, and business objectives.
• Utilize TrackWise and SAP systems to manage quality records, documentation, workflows, and related activities.
• Ensure accurate and compliant documentation of Change Controls, actions, approvals, and supporting records.
• Collaborate with internal and external stakeholders to facilitate effective communication and execution of quality-related initiatives.
• Support audits, inspections, and quality reviews by providing documentation and Change Control records as required.
• Analyze trends, identify process improvement opportunities, and recommend solutions to enhance quality system effectiveness.
• Maintain compliance with GMP, company policies, and applicable regulatory requirements.

Qualifications

Candidates must meet one of the following requirements:

• Doctorate Degree, OR
• Master’s Degree and 2 years of Manufacturing Operations experience, OR
• Bachelor’s Degree and 4 years of Manufacturing Operations 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.