Location: Medina,NY, USA
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.
Your role at Baxter
This document outlines the employment prerequisites and job responsibilities for the Inspector, Final QA position.
What sets this opportunity apart
Join Baxter Healthcare Corporation, where you will be part of a hardworking team dedicated to delivering world-class healthcare solutions. As an Inspector, Final QA, you will play a crucial role in ensuring our products meet the highest standards of quality and safety. This role offers the opportunity to work in a dynamic and collaborative environment, where your contributions will directly impact patient lives and help achieve our bold goals.
What you'll be doing
* Inspect Device History Record (DHR) documentation for infusion pumps and wireless battery modules in either paper form or the electronic Manufacturing Execution System Camstar. Verify completion of test procedures and ensure release specifications meet final acceptance criteria.
* Inspect the pump or wireless battery module to ensure it meets all visual requirements and approved labels before releasing it. Approve the release of the pump and wireless battery modules in the applicable ERP system (JDE B4ONE, JDE GME).
* Ensure there are no open nonconformances associated with the pump or wireless battery modules in the approved nonconformance tracking system.
* Review the device history log within a pump to ensure final testing has been completed in accordance with the applicable procedure.
* Accurately record all failing observations using the rework form in Camstar or the nonconformance system as applicable.
* Disposition the rework activities of nonconformances and complete 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. Inspect Service Parts and approve release of the parts.
* Assist with identification and containment of nonconforming product on the floor for internal investigations and holds.
* Perform other duties as assigned.
What you'll bring
* GED or High School education
* Preferred experience in a pharmaceutical or Biotech industry advantageous.
* Must be familiar with cGMP and FDA requirements.
* Knowledge and working application of the following:
Measurement equipment, cGMP documentation, and FDA
1. Basic ESD requirements
Computer-based programs, Data entry, and spreadsheet applications.
* Perform repetitive motions with hands/fingers.
* Proven 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 the need arises by FDA Current Good Manufacturing Practices.
We understand compensation is a meaningful 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 rate for this position is $25.95 per hour.
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 workday.
* 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 25 pounds. Must also have the capability to push and pull a maximum force of 5 pounds 4 feet.
Work Environment
Work environment characteristics described here are representative of those that must be met by an employee to optimally 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 many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
* Always wearing a static protective smock 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.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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.