Adv. Manufacturing Specialist - (US-IL-Chicago - 60827)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Responsible for implementing and maintaining the effectiveness of the quality system. Executes assigned tasks and assists in the coordination and scheduling of the manufacturing responsibilities of the department. Assists in analyzes data, evaluates results, forms conclusions, and implements process and/or document improvements. Applies scientific and technical knowledge to daily operations, data management, and problem solving. Understands and is able to assess impact of deviations from normal operating procedures and provides some direction for solutions. Understands the impact of change control and validation on products and/or processes. Participates in area metric tracking. Participates in process improvement and troubleshooting. Develops knowledge of products, processes, and technologies. Accountablility / Scope: Works independently to accomplish activities with minimal supervision. Capable of formulating conclusions and reviewing progress with others. Contributes to the definition and timely achievement of overall product/project goals. Ensures compliance. Summarizes data and reviews results with others. Makes appropriate and timely decisions. Identifies operational gaps and needs Makes recommendations for improvements and ensures follow through. Acquires and shares knowledge and experience to support continual development of self and others Accepts responsibility for own actions. May coordinate product/process activities. May lead and facilitate meetings within and/or outside of team. Communication: Listens actively and fosters information exchange within the immediate area and outside areas. Conveys scientific and operational information outside of immediate area.

Requirements :Knowledge of regulations and standards affecting IVDs and Biologics. experience includes the following: GMP/ISO requirements, Solution/chemical handling, laboratory, analytical problem solving techniques, verbal and written communication skills, statistical methods, team participation, operational processes, knowledge of performance metrics, technical documentation, computer and data management, training, document management and audits. Change control knowledge. Prefer Qualications: Highly desirable experience includes knowledge of diagnostic methods and applications, process improvement and validations. may be graded T3/T4/T5 depending on candidate's skills/experience level.

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