Job Description Description: Independently lead the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply advanced process, operational, scientific expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. Serve as the primary production process owner for critical process systems or an operational area. May supervise Manufacturing. 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. Provide troubleshooting support. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process. Lead trouble shooting of production process equipment. Generate training materials and provide training on scientific or technical aspects of the process. Participate in the design of critical processes and/or facilities. Considered to be subject matter expert in an operational area. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. Provide support of timely execution of the process monitoring quarterly reports. In conjunction with PD own process-monitoring parameters and control limits. Review process-monitoring data and assess deviations. Approve routine reports. Initiate corrective actions due to process-monitoring deviations. Ensure that all Non-conformances are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Requirements Bachelor’s degree in Sciences and 8 years of directly related experience. Experience in Trackwise System (Change Control owner), EDMQ (developing SOPs and Quality Risk Assessments), project management and validation activities Company Description PRPDG has been providing top-notch consulting services based on decades of experience. The company is armed with a staff of seasoned professionals equipped to meet the challenge of completing projects be they short-term contracts or long-term projects on time and under budget, to the cent.
Ciudad: juncos
