Specialist Manufacturing 35937

Inteldot • Juncos, PR

5d

About The Position

With minimal supervision, the Specialist Manufacturing supports execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. The role applies process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. The specialist may serve as the primary production process owner for process support systems and assist with process ownership responsibilities for more complex systems.

Requirements

• Manufacturing experience.
• One of the following education and manufacturing operations experience combinations: a master's degree and 2 years; a bachelor's degree and 4 years; an associate degree and 8 years; or a high school diploma/GED and 10 years.
• Ability to support manufacturing operations using process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure procedures reflect current operations and serve as a document owner.
• Assess process performance by observing floor operations and reviewing performance data.
• Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide process troubleshooting support.
• Assist in generating training materials and may provide training on scientific or technical aspects of the process.
• Support the establishment of process-monitoring parameters and control limits.
• Collect process-monitoring data and support assessment of deviations.
• Support timely execution of process-monitoring quarterly reports.
• Ensure non-conformances are triaged within established goals.
• Author investigation reports, execute corrective actions, and manage non-conformance and CAPA closure within established goals.
• Monitor and communicate incident trends.
• Review equipment/system root-cause-analysis investigations and support trend evaluations.
• Assist with generating process-validation protocols and reports and with executing process validation.
• Support the collection and analysis of process-validation data.
• Participate in regulatory inspections.
• Participate in the new product introduction 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 the manufacturing change owner with CCRB packages that impact the process.
• Participate in the assessment or implementation of special projects or initiatives.

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED