JT829 - SPECIALIST MANUFACTURING

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, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing to a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

• Support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and New Product Introductions (NPI).
• Apply process, operational, scientific, compliance, analytical, and troubleshooting skills to support manufacturing operations.
• Serve as a primary process owner for assigned production process support systems and assist with process ownership activities for more complex systems.
• Initiate, revise, and approve manufacturing procedures to ensure documentation accurately reflects current operations.
• Serve as a document owner and ensure procedures remain current and compliant with applicable requirements.
• Assess process performance through floor observations, operational data review, and process monitoring.
• Identify process improvement opportunities and support the planning and implementation of solutions.
• Provide technical process troubleshooting support to manufacturing operations.
• Assist in developing training materials and provide training on scientific and technical aspects of manufacturing processes.
• Support the establishment of process monitoring parameters and control limits.
• Collect and analyze process monitoring data and support the assessment and resolution of deviations.
• Support the timely preparation and execution of quarterly process monitoring reports.
• Ensure manufacturing Non-Conformances (NCs) are appropriately triaged within established timelines.
• Author and document Non-Conformance investigation reports.
• Execute corrective actions and support the timely closure of NC/CAPA activities.
• Monitor incident trends and communicate findings to relevant stakeholders.
• Review equipment and system Root Cause Analysis (RCA) investigations and support trend evaluations.
• Assist with the development of process validation protocols and reports.
• Support execution of process validation activities and collection and analysis of validation data.
• Participate in regulatory inspections, New Product Introductions, and process or equipment modification activities, as required.
• Support NPI activities by assessing requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for process and equipment modification projects.
• Assist manufacturing change owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.
• Participate in the assessment and implementation of special projects and process improvement initiatives.
• Collaborate with Manufacturing, Process Development, Quality, and other cross-functional teams to resolve technical and operational issues.
• Support other manufacturing, quality, and engineering activities as assigned.

Qualifications

• Bachelor’s degree + 4 years of Manufacturing Operations experience
• Direct pharmaceutical or biotechnology manufacturing experience.
• Strong hands‑on experience providing floor support in GMP manufacturing operations.
• Experience authoring, revising, and approving manufacturing procedures.
• Experience with NC/CAPA investigations and closure.
• Experience with process validation protocols, execution, and data analysis.
• Experience supporting NPI activities and Change Control/CCRB packages.
• Experience with process monitoring, trending, and basic statistical/control charting techniques.
• Experience leading or participating in cross‑functional manufacturing improvement projects
• Detailed technical understanding of bioprocessing unit operations.
• Hands‑on experience supporting GMP manufacturing operations.
• Experience providing on‑the‑floor manufacturing support and assessing process performance through observation and data review.
• Experience with process troubleshooting and process improvement activities.
• Knowledge of manufacturing and quality systems, including Non‑Conformances, CAPA, Change Control, and process validation.
• Experience initiating, revising, or maintaining manufacturing procedures and technical documentation.
• Knowledge of process monitoring, control limits, and basic control charting.
• Understanding of regulatory requirements and experience supporting regulatory inspections is preferred.
• Schedule: 8‑hour shift, 8:00 AM–5:00 PM.
• Ability to work overtime based on business needs.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.