Inspector, Final QA

Baxter•Medina, NY

4d•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. Your Team Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce.

Requirements

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.
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.

Nice To Haves

Experience in a pharmaceutical or Biotech industry helpful.

Responsibilities

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.

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
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