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About
Shift Timing : Monday to Thursday, 5:30 AM -4:00 PM Schedule : 4 days / 10 hours shift
Position Summary:
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. Background & Context:
Support manufacturing quality activities within an FDA-regulated manufacturing environment. Key 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 product on the floor for internal investigations and holds.
* Perform other duties as assigned. Qualification & Experience:
* 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.
* High School diploma or GED.
* Preferred experience in a pharmaceutical or Biotech industry helpful.
* Must be familiar with cGMP and FDA requirements. Working Conditions & Physical Demands:
* Must be able to sit for most of the workday.
* Ability to stand or walk for long periods as well.
* Must have good hand to eye coordination and dexterity.
* Physical Requirements: Dynamic Lifting capability: Must have the ability to lift and carry 25 pounds. Must also have the capability to push and pull a maximum force of 5 pounds 4 feet.
* Wearing a static protective smock at all times while in the work area
* Wearing a ground wrist strap and plugging that wrist strap into the working table if at an ESD sensitive station.
* Working in close proximity to other employees.
* Working in an environment that is temperature and humidity controlled. Additional Information:
This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture
Languages
- English
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