Inteldot has over 14 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 shift (8 hours)

Job Description:

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.

Administrative shift

Job Requirements:

Experience with CAPA, Change Control in the manufacturing areaOperating Systems: VEEVA and Trackwise

General Functions:

Applied Process Expertise

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.

Process Monitoring

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, Change control and CAPA

Ensure that all Non-conformances 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.

Process Validation

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

New Product Introductions & 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:

Doctorate or Masters + 2 years of Manufacturing operations experience or Bachelors + 4 years of Manufacturing operations experience or Associate + 8 years of Manufacturing operations experience or High school/GED + 10 years of Manufacturing operations experience.