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Inspector, Final QABaxter • Medina, Ohio, United States
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Inspector, Final QA

Baxter
  • US
    Medina, Ohio, United States
  • US
    Medina, Ohio, United States
Jetzt Bewerben

Über

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 So many facets of life are made better by Baxter. This is the team that seems to do that: 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.
What you’ll be doing
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.
Approve the release of the device and wireless battery modules in the appropriate ERR system, as applicable (JDE B4ONE, JDE GME, Pump Tracker).
Ensure there are no open nonconformances associates with device or wireless battery modules exist in the approved NCR system (QCBD, Trackwise).
Review 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.
Channel 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.
What you’ll bring
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.
PHYSICAL DEMANDS
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.
WORK ENVIRONMENT
This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
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.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a pay rate of $27.55 an hour.
US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and 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, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter.
Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal.
Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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  • Medina, Ohio, United States

Sprachkenntnisse

  • English
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