Biotech GMP Quality Manufacturing Specialist

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico & USA seeks a Manufacturing Operations Specialist to support GMP operations and quality systems. You will drive non-conformance investigations, CAPA, change control, and process validation activities across production lines.

Join a collaborative team focused on process monitoring, data analysis, and regulatory readiness, while ensuring training and documentation support continuous improvement. Working hours are an 8-hour shift with overtime as needed.

Qualifications

• Bachelor’s degree with 4+ years in manufacturing operations.
• Direct pharmaceutical or biotechnology manufacturing experience.
• Hands-on floor support in GMP environments.
• Experience with NC/CAPA investigations and closure.
• Experience with process validation protocols and data analysis.
• Experience supporting NPIs and Change Control/CCRB packages.
• Knowledge of process monitoring, control charts, and trending.
• Regulatory inspections experience preferred.
• Ability to work 8:00 AM–5:00 PM with overtime as needed.

Responsibilities

• Support manufacturing and quality systems including non-conformances and process validation.
• Serve as primary process owner for production support systems.
• Draft and revise manufacturing procedures.
• Perform floor observations and data review to assess process performance.
• Identify process improvements and implement solutions.
• Provide on-the-floor troubleshooting for manufacturing operations.
• Prepare quarterly process monitoring reports.
• Assist with regulatory inspections and NPI activities.
• Support Change Control Review Board (CCRB) packages.

Skills

GMP operations

Floor support

Process monitoring

Root cause analysis

Cross-functional teamwork

Education

Bachelor’s degree

Job description

Quality Consulting Group, LLC in Puerto Rico & USA seeks a Manufacturing Operations Specialist to support GMP operations and quality systems. You will drive non-conformance investigations, CAPA, change control, and process validation activities across production lines.

Join a collaborative team focused on process monitoring, data analysis, and regulatory readiness, while ensuring training and documentation support continuous improvement. Working hours are an 8-hour shift with overtime as needed.