Quality Technician II - Days - A Shift

12-hour Days Shift, 2-2-3 schedule (8:00 AM – 8:00 PM).

Responsibilities

• Oversee Quality Assurance activities for the assigned Value Stream on shift.
• Support Quality Inspectors (Visual & Dimensional) in product release activities, using product expertise to make “grey area” decisions regarding product quality.
• Conduct Batch History Record (BHR) review on a shift-to-shift basis, ensuring the BHR is ready for handoff to the next shift.
• Create Certificate of Conformance (C of C) / Certificate of Analysis (C of A) and perform the first level of BHR Review to complete the batch if it ends on the assigned shift.
• Investigate Non-Conforming Material Reports (NCMR) and Customer Complaints (CC), providing results to the Sr. Quality Lead and Quality Engineer.
• Complete Incoming Inspections in accordance with approved Inspection Plans (IIP’s).
• Comply with all PPE requirements and coach employees on adherence.
• Ensure documentation practices comply with cGMP requirements, eliminating uncontrolled documents and auditing for errors.
• Apply and support 5S, Lean, Visual Factory, and other Operational Excellence principles as they pertain to Quality Control.
• Provide guidance to Quality Control inspectors to improve product quality decisions.
• Drive appropriate work priorities for Quality Assurance based on product release needs.
• Instill a culture of continuous improvement and urgency in Quality Control, including the effectiveness and efficiency of Quality Plans.
• Keep Sr. Quality Leads updated on Quality Control issues and present BHR for final review and product release.
• Foster an environment where feedback from Quality Inspectors is encouraged and acted upon.
• Communicate with Operations and Material Handling personnel to support production priorities, including changeovers and start-ups.
• Perform BHR Review during and at the end of the shift, verifying cGMP compliance, accuracy, and proper documentation of product quality.
• Complete the first phase of final BHR Review and C of C / C of A when a batch ends on the assigned shift.
• Investigate NCMR and CC in accordance with procedures and work instructions.
• Update Defect Libraries to document product quality decisions and communicate them to Quality Inspectors.
• Perform Incoming Inspection in accordance with Approved Inspection Plans (IIP’s).
• Perform other duties as assigned.

Requirements

• High School Diploma or GED.
• 1–3 years minimum related experience in support of a manufacturing floor.
• Or equivalent combination of education and experience.