Manufacturing Quality & Process Improvement Specialist

Inteldot; Puerto Rico; On-site; USD 85,000 - 115,000; Full time

Job summary

Inteldot, a 15+ year life science partner, seeks an Administrative Shift professional to support manufacturing and quality systems in Puerto Rico. You will handle non-conformances, process validation, procedures, training, and new product introductions under minimal supervision.

Key tasks include owning documents, driving process improvements, and assisting in training and regulatory support. This role requires strong change control expertise and hands-on TrackWise/SAP experience.

Qualifications

• Doctorate or Master's in a relevant field with manufacturing operations experience, or Bachelor's with 4 years, or Associate's with 8 years, or high school/GED with 10 years.
• Experience handling change controls and quality records review in a regulated environment.
• Hands-on TrackWise and SAP experience is required.
• Strong communication and cross-functional collaboration skills are essential.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure procedures reflect current operations; serve as document owner.
• Assess process performance from floor observations and data reviews; plan and implement improvements.
• Provide troubleshooting support across manufacturing operations.
• Assist in generating training materials and delivering technical training when needed.
• Support establishment of process monitoring parameters and control limits; collect data and assess deviations.
• Support timely execution of quarterly process monitoring reports and manage NC/CAPA closures.
• Author investigation reports and drive corrective actions within goals.
• Monitor incident trends and assist with root cause analysis and trend evaluations.
• Assist with generation of process validation protocols/reports and execution of validation.
• Participate in regulatory inspections, NPI, and process or equipment modifications.

Skills

Change Control

Quality records review

Analytical troubleshooting

Communication & collaboration

Education

Doctorate OR Master's + 2 years manufacturing operations experience

Bachelor's + 4 years manufacturing operations experience

Associate's + 8 years manufacturing operations experience

High school/GED + 10 years manufacturing operations experience

Tools

TrackWise

SAP

Job description

Inteldot, a 15+ year life science partner, seeks an Administrative Shift professional to support manufacturing and quality systems in Puerto Rico. You will handle non-conformances, process validation, procedures, training, and new product introductions under minimal supervision.

Key tasks include owning documents, driving process improvements, and assisting in training and regulatory support. This role requires strong change control expertise and hands-on TrackWise/SAP experience.