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Quality Tech II for A Shift

Req ID: J2298103

  • Ubicación
    Asheville, Carolina del Norte, Carolina del Norte, United States of America
  • Categoría Grupo de Calidad
  • Publicado viernes, 17 de diciembre de 2021
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

Quality Technician is responsible to oversee Quality Assurance activities for their Value Stream on their assigned shift. This position is responsible to support Quality Inspectors (Visual & Dimensional) in product release activities, using product expertise to make “grey area” decisions regarding product quality. This position conducts Batch History Record (BHR) review on a shift-to-shift basis, assuring that the BHR is ready to be handed off to the next shift, and creates the C of C / C of A and performs the first level of BHR Review to complete the batch if it ends on the assigned shift. This position is also responsible to investigate Non-Conforming Material Reports (NCMR) and Customer Complaints (CC), providing results to the, Sr. Quality Lead and Quality Engineer as well as completing Incoming Inspections in accordance to approved IIP’s.

▪ Complies with all PPE requirements and coaches and supports all employees’ adherence.
▪ Helps to ensure that documentation practices comply with cGMP requirements – i.e., eliminates sticky notes and other uncontrolled documents in the wing and audits documentation for errors.
▪ Learns to apply and support 5S, Lean, Visual Factory and other OpEx principles as they pertain to Quality Control.

▪ Provides guidance to Quality Control inspectors and coaches them to help them make more effective product quality decisions.
▪ Understands and helps to drive appropriate work priorities for Quality Assurance that accurately reflect product release needs as determined by customer service and production planning.
▪ Instills a culture of continuous improvement and helps ensure an appropriate sense of urgency in all aspects of Quality Control, including the effectiveness & efficiency of Quality Plans.

▪ Keeps Sr. Quality Leads updated on Quality Control issues and status, presenting BHR to the appropriate Sr. Quality Lead for final review and product release when completed.
▪ Provides guidance to Quality Inspectors and creates an environment where input and feedback are encouraged and acted upon as appropriate.
▪ Communicates with Operations and Material Handling personnel to support production priorities including changeovers and start-ups.

Performs BHR Review during and at the end of the shift and verifies cGMP compliance, accuracy and that objective evidence of product quality have been properly documented, including C of C / C of A completion and the first phase of final BHR Review when a batch ends on the assigned shift.
▪ Investigates NCMR & CC in accordance with associated procedures & work instructions.
▪ Updates Defect Libraries as needed to document product quality decisions and communicate them to Quality Inspectors for consistent future application.
▪ Performs Incoming Inspection in accordance to the Approved Inspection Plans (IIP’s)

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