Quality Associate II

Baxter International Inc.; Round Lake (IL); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player in healthcare is seeking a dedicated Quality Assurance professional to manage and coordinate activities within the documentation center and batch release team. This pivotal role involves ensuring compliance with established standards, regulations, and specifications while maintaining the safety and quality of products. You'll engage with various teams to address batch-related concerns, implement process efficiencies, and lead multiple improvement projects. If you have a passion for quality and a commitment to excellence, this is your chance to make a significant impact in a role that truly saves and sustains lives.

Qualifications

• 3+ years of experience in Quality or Manufacturing field.
• Bachelor’s degree required, preferably in engineering or science.

Responsibilities

• Manage documentation and data requests from Pharma clients.
• Review and approve batch and systems documentation.

Skills

Problem Solving

Analytical Skills

Interpersonal Skills

Project Management

Leadership

Education

Bachelor’s degree in Engineering or Science

Tools

JDE

GME

Trackwise

Labvantage/Laboratory LIMs

IDBS E-WorkBook

Job description

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.

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.