JT829 - SPECIALIST MANUFACTURING

QUALITY CONSULTING GROUP, a leader in the 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.

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