Quality Inspector

Baxter•Skaneateles Falls, NY

11d•Onsite

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

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.
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 DHR documentation for devices and modules either on paper 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 device or module, including approved labels, are met prior to release of device or 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 module in the appropriate ERP system, as applicable
Ensures there are no open nonconformances associates with device or module exist in the approved NCR system (SAP).
Reviews the event history log within a device to ensure values have been accurately entered in the required testing values or results recorded in the DHR.
Accurately record all failing observations using the minor correction process and/or electronic 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.
Adding QA flags to all received product using the appropriate ERP system
Inspect and perform QA release activities of Spare Parts Kits.
Assist with identification and containment of nonconforming product on the floor for internal investigations and holds.
Perform other duties as assigned.

Benefits

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), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
time-off benefits such as 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