Specialist Manufacturing

Location: Juncos, PR
Date Posted: 01-08-2015
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. Serve as a document owner. Responsible for managing NC/CAPA closure within established goal. Monitor and communicate incidents trends.

Duties and Responsibilities:
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 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.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

Skills and Specifications:
- Detailed technical understanding of bioprocessing unit operations.
-Skilled in performance of GMP production operations.
-Regulatory knowledge and interactions.  
-Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
-Organizational, technical writing and presentation skills.

Ultimate Solutions Corp is an Equal Opportunity Employer.
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