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Area Este PR 00600 Area Este

DescripciónDescription

With minimal supervision, 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.

Requisitos Requirements Master's degree and 3 years of Manufacturing Operations experience or Bachelor's degree and 5 years of Manufacturing Operations experience or Associate’s degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience Experience in the development and/or manufacturing of bio-processes Working knowledge of pharmaceutical/biotech processes Skilled in performance of GMP production operations Regulatory knowledge and interactions Organizational, technical writing and presentation skills. Project management skills Knowledge of control charting and basic statistics Perform deviations assessments and support deviation lead during the root cause, human performance evaluation, CAPA development, and closure of record within established goal. Execute action owner responsibilities for CAPA records. Monitor effectiveness of CAPA implemented to prevent recurrence of dev

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