Specialist Manufacturing (Puerto Rico)

Specialist Manufacturing (Puerto Rico)

12 jun
|
Ultimate Solutions
|
Puerto Rico

12 jun

Ultimate Solutions

Puerto Rico

Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the general leaders of pharmaceutical, biotechnology, medical devices and logistics markets.

DESCRIPTION

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.
- Ensure that all Non-conformances (NC) are triaged within the established goal.
- Responsible for authoring investigation reports.
- Responsible for execution of corrective actions.
- Responsible for 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.
- Assist with the execution of the process validation.
- Support collection and analysis of process validation data.
- May participate in regulatory inspections
- Participate in the New Product Introduction (NPI) process to assess requirements for documentation, materials, training, and equipment modifications.
- Assess, prioritize, justify, and provide implementation and project management support

📌 Specialist Manufacturing (Puerto Rico)
🏢 Ultimate Solutions
📍 Puerto Rico

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