Process & Quality Specialist — Life Sciences

Inteldot; Juncos (PR); On-site; USD 65,000 - 85,000; Full time

Job summary

Inteldot in Puerto Rico is seeking an Administrative Shift professional to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions, with minimal supervision.

The candidate should bring strong Change Control expertise, knowledge of TrackWise and SAP, plus the ability to collaborate across teams to drive process improvements on the floor.

Qualifications

• Experience with Change Control processes.
• Ability to triage NC/CAPA within established goals.
• Hands-on experience with TrackWise and SAP.

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.Non-Conformance and CAPA
• Ensure that all non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist with generation of process validation protocols and reports and with the execution of the process validation.
• Support collection and analysis of process validation data.
• Participate in regulatory inspections, New Product Introductions, and Process or Equipment Modifications:
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Assist manufacturing change owner on CCRB packages impacting the process.

Skills

Change Control

Critical thinking

Communication

Collaboration

Results-oriented

Education

Doctorate or Master’s

Bachelor’s with 4 years experience

Associate’s with 8 years

High school/GED with 10 years

Tools

TrackWise

SAP

Job description

Inteldot in Puerto Rico is seeking an Administrative Shift professional to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions, with minimal supervision.

The candidate should bring strong Change Control expertise, knowledge of TrackWise and SAP, plus the ability to collaborate across teams to drive process improvements on the floor.