QA Inspector

Stefanini Group•Medina, NY

4d•Onsite

About The Position

Stefanini Group is looking for a QA Inspector in Medina, NY. This role involves performing inspections of Device History Record (DHR) documentation for infusion pumps and wireless battery modules, either on paper or in the electronic Manufacturing Execution System (Camstar). The inspector ensures that test procedures have been completed and release specifications are met for final acceptance and release. Additionally, they will inspect the physical pump or wireless battery module for visual aspects, including approved labels, before release. The QA Inspector approves the release of products in the appropriate ERP system (JDE B4ONE, JDE GME), ensures no open nonconformances exist in the approved tracking system, and reviews device history logs to confirm final testing compliance. They are responsible for accurately recording failing observations, managing rework activities, and completing the electronic approval and closure process for non-conformances. The role also includes ensuring process control and maintenance procedures are followed, recognizing and acting on out-of-compliance situations, and inspecting/approving service parts for release. Assisting with the identification and containment of nonconforming products on the floor for investigations and holds is also part of the responsibilities. Other duties may be assigned.

Requirements

High School diploma or GED.
Must be familiar with cGMP and FDA requirements.
Knowledge and working application of measurement equipment.
Knowledge and working application of cGMP documentation and FDA.
Knowledge and working application of Basic ESD requirements.
Knowledge and working application of Computer-based programs.
Knowledge and working application of Data entry and spreadsheet applications.
Perform repetitive motions with hands/fingers.
Demonstrated attention to details and accuracy, required.
Must have good communication skills.
Ability to visually inspect and identify particulate/foreign matter and distinguish between colors as required by FDA Current Good Manufacturing Practices.

Nice To Haves

Preferred experience in a pharmaceutical or Biotech industry helpful.
May be required to work flexible hours and overtime on short notice.

Responsibilities

Perform the inspection of Device History Record (DHR) documentation for infusion pumps and wireless battery modules for final acceptance and release.
Perform inspection of the pump or wireless battery module to ensure all visual aspects, including approved labels, are met prior to release.
Approves the release of the pump and wireless battery modules in the appropriate ERP system.
Ensures there are no open nonconformances associated with the pump or wireless battery modules in the approved nonconformance tracking system.
Reviews the device history log within a pump to ensure final testing has been completed in accordance with the applicable procedure.
Accurately record all failing observations using the rework form in Camstar or the nonconformance system.
Dispositions the rework activities of nonconformances and completes the electronic approval and closure process for any non-conformances.
Ensure process control and maintenance procedures are being followed.
Recognize out of compliance/out of tolerance situations and take appropriate action.
Inspect Service Parts and approve release of the parts.
Assist with identification and containment of nonconforming products on the floor for internal investigations and holds.
Perform other duties as assigned.