JT829 - SPECIALIST MANUFACTURING

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, 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