Specialist Manufacturing 35321

Inteldot•Juncos, PR

20h•Onsite

About The Position

Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, United States, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. 8 hours Shift | OT based on business needs. 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.

Requirements

Experience in Manufacturing area, specifically writing procedures, managing document in management system (document workflow)

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.
Support establishment of process monitoring parameters and control limits.
Collect process-monitoring data and support the assessment of deviations.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Responsible for managing NC/CAPA closure within established goal.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Assist with generation of process validation protocols and reports.
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
Assist manufacturing change owner on CCRB packages impacting the process.