Inspector, Final QA

• Perform the inspection of ICL documentation for infusion pumps (devices) and wireless battery modules either on paper or in the electronic Global Service Platform (GSP) system in order to ensure test procedures have been completed and release specifications are within specifications for final device acceptance and release.
• Perform internal inspection of devices to ensure all visual aspects of the pump or wireless battery module, including approved labels, are met prior to release of device or wireless battery module.
• Verify that all customer facing device and packing labels are accurate and match the serial number being inspected.
• Approves the release of the device and wireless battery modules in the appropriate ERR system, as applicable (JDE B4ONE, JDE GME, Pump Tracker)
• Ensures there are no open nonconformances associates with device or wireless battery modules exist in the approved NCR system (QCBD, Trackwise).
• Reviews the event history log within a device to ensure calibration values have been accurately entered in the pump using release testing values recorded in GSP.
• Channels accepted or rejected products to the appropriate locations on the service floor.
• Accurately record all failing observations using the minor correction process and/or electronic nonconformance system (QCBD or Trackwise) 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 an approved electronic system.
• Review for accuracy and accept the quality data entry of service events using the Medina Service Trending Site in SharePoint.
• Ensure process control and maintenance procedures are being followed.
• Recognize out of compliance/out of tolerance situations and take appropriate action.
• Adding QA flags to all received product using the appropriate ERP system (JDE B4ONE, Pump Tracker)
• Inspect and perform QA release activities of Spare Parts Kits in service.
• Assist with identification and containment of nonconforming product on service floor for internal investigations and holds.
• Perform other duties as assigned.

• Bachelors’ degree with 0-2 years related experience or Associates with 1-3 years-related experience or High School diploma with 2-4 years experience. Experience in a pharmaceutical or Biotech industry helpful.
• Must be familiar with cGMP and FDA requirements. Knowledge of aseptic techniques may be required.
• Knowledge and working application of the following: Measurement equipment. Knowledge of basic ESD requirements
• Computer based programs. Data entry and spreadsheet applications.
• Perform repetitive motions with hands/fingers.
• Knowledge of cGMP documentation and FDA required.
• Demonstrated attention to details and accuracy, required.
• Must have good communication skills.
• May be required to work flexible hours and overtime on short notice.
• Must be able to sit for most of the work day.
• Ability to: stand or walk for long periods, lift and carry at least 20 pounds
• must have good hand to eye coordination and dexterity

Experience in a pharmaceutical or Biotech industry helpful

• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP)
• 401(k) Retirement Savings Plan (RSP)
• Flexible Spending Accounts
• educational assistance programs
• paid holidays
• paid time off ranging from 20 to 35 days based on length of service
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits