Responsibilities
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- Develop, write, review, and execute process validation/process verification protocols and reports.
- Conduct risk assessments and develop validation strategies for new and existing processes.
- Analyze and interpret process validation data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
- Collaborate with Manufacturing, Quality, Design Transfer Operations, and other departments to resolve validation issues and implement corrective actions.
- Participate in process optimization and continuous improvement initiatives to enhance quality and efficiency.
- Ensure compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements.
- Provide training and guidance to manufacturing and quality personnel on validation processes and procedures.
- Maintain process validation documentation and ensure traceability and accessibility for audits and inspections.
- Other duties as assigned by management.
- Bachelor's Degree in Engineering or Life Science.
- Strong technical writing, analytical, and problem-solving skills.
- Knowledge of cGMP and regulatory standards.
- Strong understanding of process validation principles, techniques, and industry standards.
Pay ranges between $32-42/hr based on experience
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