Specialist Manufacturing 35937

Inteldot; Juncos (PR); In loco; USD 42.000 - 72.000; Tempo pieno

Descrizione del lavoro

Inteldot in Puerto Rico seeks a hands-on Administrative & Non Standard Shift professional to support manufacturing and quality systems. You will work with non-conformances, process validation, procedures, training, and new product introductions.

The role requires operating with minimal supervision and applying process knowledge to improve plant performance. On-the-floor oversight includes initiating and updating procedures, troubleshooting, and contributing to NPI documentation and training.

Competenze

• Manufacturing experience required.
• On-the-floor support to assess process performance by observation and data review.
• Initiate, revise, and approve manufacturing procedures.
• Provide process troubleshooting support.
• Assist in NPI documentation, training, and equipment changes.

Mansioni

• Initiate, revise, and approve manufacturing procedures; ensure current operations are reflected.
• Assess process performance through floor observations and data review; plan improvements.
• Provide troubleshooting support for manufacturing processes.
• Assist in generating training materials and delivering training on process aspects.
• Support process monitoring parameters, data collection, and deviation assessments.
• Support timely execution of quarterly process monitoring reports and NC/CAPA closure.

Conoscenze

Manufacturing Experience

Formazione

Master’s + 2 years of Manufacturing Operations experience

Descrizione del lavoro

Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative & Non Standard Shift

Description:

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

Knowledge & Requirements:

• Manufacturing Experience
• On the floor support to Assess process performance by observation of floor operations and review of performance data.
• Initiate, revise, and approve manufacturing procedures.
• Provide process troubleshooting support.
• Participate in the NPI process to assess requirements for documentation, materials, training.
• Assist manufacturing change owner on CCRB packages impacting the process
• Participate on the assessment or implementation of special projects or initiatives

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.

Education:

• Master’s + 2 years of Manufacturing Operations experience OR Bachelors + 4 years of Manufacturing Operations experience OR Associates + 8 years of Manufacturing Operations experience OR High school/GED + 10 years of Manufacturing Operations experience