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:

You will 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.

Your Team

Baxter is focused on saving and sustaining lives by finding solutions to sophisticated problems. Every single day, the manufacturing team strives to create quality products for our customers—and are sometimes met with unforeseen issues to tackle. The high-caliber talent at Baxter meets these challenges head-on, as a team, to create products with the customer's needs top-of-mind.

We build relationships with each other to get work done.

We provide opportunities for you to continue to learn through training, conferences, certifications, and support for advanced degrees. Growth from role to role or level to level is encouraged and is supported by management to ensure employees are consistently engaged with their work.

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 the ability to apply 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 on a daily basis 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.

• Must be able to manage multiple tasks and projects simultaneously.

• Manage activities of self and is considered a team lead for Technicians, in achieving defined safety and quality goals.

• Should be able to 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, handles, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements.

• Works with minimal direction.

• Ability to 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.

• Detailed knowledge of applicable regulations and standards.  Strong analytical/problem solving skills.

• Ability to manage/supervise a team of employees.  Ability to contribute to and lead project teams.

• Must be able to lift 30 pounds.  Must not be allergic to Penicillin or Cephalosporin drugs.

• Knowledge of JDE, GME, Trackwise, Labvantage/Laboratory LIMs, and IDBS E-WorkBook a plus

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

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 salary range of $60,000 to $90,000 and also includes an annual incentive bonus, commission target. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location

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The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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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Qualifications:

Salary : $60,000 - $90,000