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Roles and Responsibilities Position Summary:
(Please describe in 2 - 4 sentences the major duties and responsibilities of this position.)
The Quality Technician is responsible to oversee Quality Control activities for their Value Stream on their assigned shift. This position is responsible to support Inspector Packers and Quality Inspectors 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 site leadership team, Quality Lead and/or the Quality Engineer.
Safety, cGMP and Operational Excellence
o Complies with all PPE requirements and coaches and supports all employees’ adherence.
o 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.
o Learns to apply and support 5S, Lean, Visual Factory and other OpEx principles as they pertain to Quality Control.
o Provides guidance to Quality Control inspectors and coaches them to help them make more effective product quality decisions.
o Understands and helps to drive appropriate work priorities for Quality Control that accurately reflect product release needs as determined by customer service and production planning.
o 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 Control Plans.
o Keeps Quality Manager and Quality Leads updated on Quality Control issues and status, presenting BHR to the appropriate Quality Lead for final review and product release when completed.
o Provides guidance to Inspector Packers and Quality Inspectors and creates an environment where input and feedback are encouraged and acted upon as appropriate.
o Communicates with Operations and Material Handling personnel to support production priorities including changeovers and start-ups.
Systems and Equipment
o 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.
o Investigates NCMR & CC in accordance with associated procedures & work instructions.
o Updates Defect Libraries as needed to document product quality decisions and communicate them to Quality Inspectors for consistent future application.
Organization Linkages: List the titles of individuals and organizations with which this position has the most frequent and significant contact. Briefly describe the nature of those contacts.
o Quality Manager or Quality Engineer – direct line supervisor for this position; provides current status of Quality Control including, NCMR investigations & CAPA / improvement projects; presents opportunities for improvement.
o Quality Lead – receives product quality training and aligns product quality expectations; provides the completed BHR for final review & product release.
o Quality Inspectors (Visual & Dimensional) – provides product expertise and guidance as needed to assure effective shift-to-shift Quality Control and product quality decisions.
o Production Supervisors – shares information regarding product quality, compliance and personnel performance to assist in effective personnel management in Operations; discusses quality issues & NCMR as needed to facilitate effective resolution.
o Group Leads – shares information regarding product quality, compliance and personnel performance to assist in effective day-to-day operations and personnel management in Operations.
o Quality Engineers – provides CC investigation results.
Job Specifications: The minimum education and experience required to perform this job competently:
· 2 years Quality Control experience
· 1 year Jabil or medical device Quality Inspection experience
· Excellent computer skills including proven ability to master proprietary software; NWQS and SAP experience preferred