Specialist Manufacturing

For process onwer services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree with five(5)years of Manufacturing Operations experiencewithin the pharmaceutical or regulated industry.
Shift: Administrativeand according to business needs.
Experience in: Procedure Development
Change Control
CAPA
Deviation (Minor & Major)
Risk Assessment

The Personality Part:
We know you know the Manufacturing language to perfection, but how about talking with Process Development? And Quality? And any and all other areas in the industry? If you're confident in those communicating skills of yours and give value to teamwork, the scientific method and, above all else, being ethical, then this might be the job for you! Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
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.
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 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 evaluation.
Assist with generation of process validation protocols and reports.
May participate in regulatory inspections
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.
Participate on the assessment or implementation of special projects or initiatives.
WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent. We're FITS!
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