Quality Inspector

Job description

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. BUSINESS TITLE Inspector, Final QA DEPARTMENT Quality JOB TITLE Inspector, Final QA REPORTS TO Manager, Operations Quality JOB CODE 10-Step-USA01-Inspector-300483 VERIFIED BY Human Resources GRADE/FLSA HNE REVISION DATE 2/23/2021 I. SUMMARY: This document outlines the employment prerequisites and job responsibilities for the Inspector, Final QA position II. ESSENTIAL FUNCTIONS: • 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. III. QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED: • Knowledge and working application of the following: • Measurement equipment. • cGMP documentation and FDA • Basic ESD requirements • Computer based programs • 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 IV. EDUCATION/EXPERIENCE REQUIRED: Ø High School diploma or GED Ø Preferred experience in a pharmaceutical or Biotech industry helpful. Ø Must be familiar with cGMP and FDA requirements. V. 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: Ø Must be able to sit for most of the work day. Ø Ability to stand or walk for long periods as well. Ø Must have good hand to eye coordination and dexterity Ø 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. VI. WORK ENVIRONMENT: Work environment characteristics 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. This is a manufacturing environment regulated by the FDA and ma 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 .