Quality Technician II B Shift

Job Description

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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