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Job: Process Specialist, Advanced Recruiting Partners, Morrisville, NC

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General Information

Job title:
Process Specialist
Job location:
Morrisville, NC  27560 United States
Requisition code:
Date posted:
Job category:
Manufacturing and Production
Employment type:
Full time

Job Description

Position Summary:
The Process Specialist will support manufacturing operations both directly and indirectly. The primary role for this position is to write procedures, deviations, validations, and other production documentation. The process specialist will spend a portion of their time on the production floor and will be trained and qualified to execute the process. They will assist in troubleshooting equipment and process issues, create or modify processes, and develop subject matter expertise.
• Author validation documentation such as user requirements specifications, design reviews, periodic reviews, installation and operational qualifications, performance qualifications, and process validations
• Author deviations, environmental excursions, procedures, and change controls
• Execute corrective action plans
• Train and mentor production personnel
• Operate and troubleshoot production equipment including the following: process reactors, dryers, tube fillers, centrifuge, and milling equipment
• Support review of production documentation
• Perform other duties as assigned

Job Requirements

• Strong mechanical aptitude and critical thinking
• Attention to detail and good documentation skills
• Strong verbal and written communication skills
• Honest, flexible, dependable, self-motivated team player with the demonstrated ability to work
independently. Willingness to accept responsibility and work assignments
• Ability to prioritize workload and manage time to complete multiple projects within established
timelines and goals with minimal supervision in a fast-paced environment
• College Degree in Science or Engineering, or equivalent experience
• Proficiency in MS office software
• Four or more years of experience in a GMP manufacturing environment
• Prior experience writing deviations, procedures, validations, and corrective actions
• Prior experience managing change control
(Job number: 4048460)
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