Manufacturing Quality Change Leader

qualityconsultinggroup; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a highly motivated professional to join our manufacturing quality team in Puerto Rico and the USA. You will support quality systems, drive change controls, and participate in investigations to ensure compliance across biotech, pharmaceutical, and medical device operations.

The role requires strong communication, cross-functional collaboration, and the ability to manage multiple priorities in a regulated environment.

Qualifications

• Experience in a cGMP-regulated pharmaceutical/biotech/medical device environment.
• Experience with Change Control processes and quality systems.
• Experience serving as Quality Record Owner or managing supplier-related Change Control quality records.
• Proficiency with TrackWise and SAP for quality documentation.

Responsibilities

• Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
• Own change controls for manufacturing process changes
• Lead investigations and root cause analyses for deviations and CAPA.
• Coordinate training materials and provide on-floor support.

Skills

Change Control

Quality Systems

Cross-functional

Communication

Time management

Documentation

Education

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

Tools

TrackWise

SAP

Job description

Quality Consulting Group, LLC is seeking a highly motivated professional to join our manufacturing quality team in Puerto Rico and the USA. You will support quality systems, drive change controls, and participate in investigations to ensure compliance across biotech, pharmaceutical, and medical device operations.

The role requires strong communication, cross-functional collaboration, and the ability to manage multiple priorities in a regulated environment.