Specialist Manufacturing - Juncos, PR - 35632

• 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.

Requirements

-Doctorate Or Master’s + 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.