Quality Associate II

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

Manage and coordinate routine activities and projects for the documentation center/batch release team. This will include such activities as batch review and release, systems review and release, and nonconformance and CA/PA management, while assuring compliance with established standards, regulations, specifications, and SOPs. Ensure that batch record documentation is in compliance with internal corporate/division/plant quality control programs, current Good Manufacturing Practices, current Good Documentation Practices, and external regulations. Assure the safety and quality of the products, processes, and systems.

***The candidate must not be allergic to penicillin or cephalosporin drugs ***

What you'll be doing

• Review and approval of batch and systems documentation.
• Develops, assigns and implements systems, procedures and policies to assure compliance with cGMP's and FDA regulations and company policies and procedures. Assess all plant systems, operations, products, processes, procedures, and documentation for adequacy and effectiveness to ensure Quality and Regulatory Compliance related to CA/PA.
• Applies problem solving logically and in an organized manner. Must have experience with Root Cause Analysis tools and applying tools to plant scenarios.
• Manages documentation and data requests from Pharma clients, division, Global Business Unit and product development and support functions related to QM Manufacturing Quality Assurance and batch release.
• Maintains appropriate quality metrics for Management Review.
• Will interact with manufacturing and supervision daily to address batch related concerns.
• Must have good working knowledge of plant systems, processes, procedures, documentation, and products.
• Plays an active role on quality management teams within the organization.
• Handle multiple tasks and projects simultaneously.
• Considered a team lead for Technicians, in achieving defined goals.
• Communicate at all Plant and Divisional levels.

What you'll bring

• Bachelor’s degree required, preferably in engineering or science.
• 3 or more years’ experience in Quality, Manufacturing or related field.
• Drives efforts to identify and implement process efficiencies in order to achieve established release goals.
• Seeks new ways to improve and streamline current business and system processes. Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements.
• Works with minimal supervision.
• Communicate efficiently verbally and in writing with all levels of the organization and with external clients. Good interpersonal/influencing/negotiation/leadership skills.
• Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals. Good project management skills.
• Thorough knowledge of applicable regulations and standards. Strong analytical/problem solving skills.
• Ability to supervise a team of employees, and lead project teams.
• Must lift 30 pounds.
• Knowledge of JDE, GME, Trackwise, Labvantage/Laboratory LIMs, and IDBS E-WorkBook a plus

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 $76,000 - $104,500 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. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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

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