Manufacturing Process Specialist & Change Leader

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a motivated professional to join our team in Puerto Rico/USA. You will support manufacturing quality systems, manage change controls, and assist with investigations while collaborating across functions to ensure compliant operations.

The role emphasizes documentation, training support, and hands-on process improvements, aligning with regulatory expectations and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
• Manufacturing Operation experience (not quality).
• Document Management, create new documents, review and approval of documents.
• Administrative Shift.

Responsibilities

• Support the execution of manufacturing/quality systems, including non-conformances, process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific expertise, basic compliance knowledge, and analytical skills to support manufacturing operations.
• May serve as primary production process owner for process support systems and assist with ownership on complex systems.
• Own change controls for manufacturing process changes and ensure proper documentation.
• Support investigations, root cause analysis, corrective/preventive actions, and regulatory inspection readiness.
• Contribute to risk assessments and microbial assessment evaluations.
• Assist in training material generation and provide training on technical aspects of processes.
• Provide on-floor troubleshooting and cross-functional collaboration across teams.
• Design and coordinate functional tests, water tests, and run simulations during major changes or campaigns; generate protocols.
• Assist and guide Master Batch Record creation/revisions and assess process modifications.
• Review performance data and develop solutions for process improvements.

Skills

Manufacturing operations experience

Document management

Administrative shift

Education

Bachelor's degree in Life Sciences/ Biology/ Chemistry/ Engineering

Job description

Quality Consulting Group, LLC is seeking a motivated professional to join our team in Puerto Rico/USA. You will support manufacturing quality systems, manage change controls, and assist with investigations while collaborating across functions to ensure compliant operations.

The role emphasizes documentation, training support, and hands-on process improvements, aligning with regulatory expectations and continuous improvement initiatives.