• 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.

Compétences requises

cGMP complianceChange control management (including CCRB package coordination)Process validation protocol and report generationRisk assessment and corrective action implementationRegulatory inspection supportElectronic Batch Record (EBR) alignment and managementManufacturing procedure authoring and document ownershipProcess performance assessment and floor observationProcess improvement planning and implementationTraining material development and technical training deliveryNew Product Introduction (NPI) requirements assessmentProject management for process and equipment modification projectsData collection and analysis from noncommercial/process runs

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