Specialist Manufacturing Juncos, PR 35632

Required Skills:

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 the generation of training materials and may assist in providing training on scientific or technical aspects of the process. Ensures that processes and procedures are aligned with cGMP requirements and/or other applicable regulations Responsible for ensuring that risks are identified assessed and corrected to ensure the safety purity quality and efficiency of the product(s) manufactured Responsible for ensuring that the Electronic Batch Record is aligned with the current process and may assist in providing training. Assist with generation and the implementation of process validation protocols and reports. Participate in regulatory inspections Participate in the NPI process to assess requirements for documentation materials training and equipment modifications. Assess prioritize support and provide implementation and project management support for process or equipment modification projects. Own Change Control and ensure implementation within the established goal. Assist manufacturing change owner on CCRB packages impacting the process. Participate in noncommercial activity runs to support the collection and analysis of process data Participate on the assessment or implementation of special projects or initiatives.

Required Education:

-Doctorate Or Masters 2 years of Manufacturing Operations experience OR -Bachelors 4 years of Manufacturing Operations experience OR -Associates 8 years of Manufacturing Operations experience OR -High school/GED 10 years of Manufacturing Operations experience Shift: Admin 8am-5pm OT may be required based on business needs.