QA Inspector

Stefanini Group•Medina, NY

3d•Onsite

About The Position

Stefanini Group is hiring 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 primary goal is to ensure test procedures have been completed and release specifications are met for final acceptance and release. The inspector will also visually inspect the pump or wireless battery module for all visual aspects, including approved labels, before release. The role requires approving the release of products in the appropriate ERP system (JDE B4ONE, JDE GME), ensuring no open nonconformances are associated with the products in the tracking system, and reviewing device history logs to confirm final testing compliance. Accurate recording of failing observations, dispositioning rework activities, and completing electronic approval and closure processes for non-conformances are key responsibilities. The inspector must also ensure process control and maintenance procedures are followed, recognize and act on out-of-compliance situations, and inspect and approve the release of service parts. Assisting with the identification and containment of nonconforming products on the floor for internal investigations and holds is also part of the role. Other duties may be assigned.

Requirements

High School diploma or GED.
Must be familiar with cGMP and FDA requirements.
Knowledge and working application of the following: Measurement equipment.
cGMP documentation and FDA Basic ESD requirements
Computer-based programs
Data entry and spreadsheet applications.
Perform repetitive motions with hands/fingers.
Demonstrated attention to details and accuracy, required.
Must have good communication skills.
May be required to work flexible hours and overtime on short notice.
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.

Responsibilities

Perform the inspection of Device History Record (DHR) documentation for infusion pumps and wireless battery modules either on paper or in the electronic Manufacturing Execution System Camstar to ensure test procedures have been completed and release specifications are within specifications 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 of the pump or wireless battery module.
Approves the release of the pump and wireless battery modules in the appropriate ERP system, as applicable (JDE B4ONE, JDE GME)
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 to the applicable procedure.
Accurately record all failing observations using the rework form in Camstar or the nonconformance system as applicable.
Dispositions the rework activities of nonconformances and completes the electronic approval and closure process for any non-conformances with the device in the approved electronic system.
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.