GMP Manufacturing Process Specialist

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

Job summary

Quality Consulting Group, LLC is seeking a talented Manufacturing Operations professional to join our team in Puerto Rico and the USA. You will contribute to a world-class manufacturing environment by supporting manufacturing and quality systems, developing procedures, and performing on‑the‑floor troubleshooting.

You will collaborate with cross‑functional teams to drive process improvements, investigate NC/CAPA, and support regulatory readiness while ensuring documentation accuracy and

Qualifications

• Bachelor’s degree plus 4 years of manufacturing ops experience.
• Direct pharmaceutical/biotech manufacturing experience.
• Hands-on GMP floor support in manufacturing operations.
• Experience authoring and approving manufacturing procedures.
• Experience with NC/CAPA investigations and closure.
• Process validation protocols, execution and data analysis.
• Experience with NPI activities and CCRB packages.
• Process monitoring, trending, and basic control charting.
• Lead or participate in cross-functional manufacturing improvement projects.
• Bioprocessing unit operations understanding.
• GMP manufacturing operations on the floor.
• On-the-floor support and data review for process performance.
• Process troubleshooting and continuous improvement.
• Knowledge of Non-Conformances, CAPA, Change Control, and validation.
• Maintenance of manufacturing procedures and documentation.
• Knowledge of monitoring, control limits and basic charts.
• Regulatory inspections experience preferred.
• Schedule: 8-hour shift 8:00 AM–5:00 PM.
• Overtime may be required.

Responsibilities

• Support execution of manufacturing and quality systems, incl. NCs, process validation, procedures, and NPI.
• Apply process, operational, scientific, and troubleshooting skills to support manufacturing.
• Serve as primary process owner for production support systems.
• Initiate, revise, and approve manufacturing procedures.
• Own document control and ensure procedures are current and compliant.
• Assess process performance via floor observations and data review.
• Identify process improvements and implement solutions.
• Provide technical on-floor troubleshooting support.
• Develop training materials and deliver training on manufacturing processes.
• Support process monitoring parameters and control limits.
• Collect and analyze monitoring data; address deviations.
• Prepare quarterly process monitoring reports.
• Triages NCs within timelines and document investigations.
• Execute corrective actions and close NC/CAPA activities.
• Monitor incident trends and communicate findings.
• Review RCA investigations and support trend evaluations.
• Develop process validation protocols and reports.
• Support validation activities and data collection.
• Participate in regulatory inspections, NPI and modification activities.
• Assess requirements for documentation, materials, training, and equipment for NPI.
• Support process and equipment modification projects; CCRB packages.
• Collaborate with cross-functional teams to resolve issues.
• Support other manufacturing, quality, and engineering activities.

Skills

Pharmaceutical manufacturing exposure

GMP floor support

Process monitoring

Deviation analysis

Data analysis

Cross-functional collaboration

Troubleshooting

Technical documentation

Regulatory inspections support

Education

Bachelor’s degree in Science or Engineering + 4 years manufacturing ops experience

Tools

N/A

Job description

Quality Consulting Group, LLC is seeking a talented Manufacturing Operations professional to join our team in Puerto Rico and the USA. You will contribute to a world-class manufacturing environment by supporting manufacturing and quality systems, developing procedures, and performing on‑the‑floor troubleshooting.

You will collaborate with cross‑functional teams to drive process improvements, investigate NC/CAPA, and support regulatory readiness while ensuring documentation accuracy and