Quality Inspector

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 Role at Baxter This is where your creativity addresses challenges You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Inspector you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality. You will be responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations, incoming inspection and finished product inspection. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products. Your Team at Baxter Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products. What You'll Be Doing 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. What You'll Bring High School diploma with 2-4 years related experience. Experience in a pharmaceutical or Biotech industry helpful. Must be familiar with cGMP and FDA requirements. Knowledge of aseptic techniques preferred. Knowledge of GMP documentation and FDA required. Demonstrated attention to details and accuracy required. May be required to work flexible hours and overtime on short notice. Perform repetitive motions with hands/fingers. Demonstrated attention to details and accuracy, required. Must have good communication skills. Ability to visually inspect and identify particulate/foreign matter and distinguish between colors as required by FDA Current Good Manufacturing Practices. Knowledge and working application of: measurement equipment, cGMP documentation and FDA, basic ESD requirements, computer based programs, data entry and spreadsheet applications. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee: Must be able to sit for most of the work day. 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 23 pounds.Must also have the capability to push and pull a maximum force of 5 pounds 4 feet. 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. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. 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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $44,800 - $61,600 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, 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. " #J-18808-Ljbffr