Quality Associate III (Fill/Pack) - Monday-Friday 8AM - 5PM
Baxter International Inc.About the role
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:
Optimally perform all the primary activities as defined in the QA I and QA II job positions. Handle multiple projects. Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. Lead and/or participate in Kaizen or equivalent focus type group activities. Design, lead and perform experiments using sound scientific principles. A functional understanding of FDA, ISO and Baxter Quality systems is also required.
Your Team at Baxter
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
What we offer from Day One
- Medical, Dental and Vision coverage
- 160 hours of Paid Time Off and Paid Holidays
- 401K match
- Employee Stock Purchase Program
- Paid Parental Leave
- Tuition Reimbursement
What you'll be doing:
- Learn, understand, review and apply Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).
- Perform and/or verify correction and containment activities and review documentation of these activities when process anomalies occur (EMW and NCR).
- When required, assist other Quality areas by leading departmental activities including supervision of assigned personnel.
- Be directly involved in, and where appropriate, lead multiple process/product improvement projects which may include Kaizen, or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
- Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements.
- Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and when needed, assist and support such activities throughout the facility.
- Provide guidance and coaching for the areas of responsibility for less experienced individuals within the plant.
- Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
- Must have the ability to perform the responsibilities of the Quality Section Manager on an as needed basis.
- Assists and reviews validations for equipment, product changes and computer systems.
- Assists with and reviews vendor audits/assessments and provides ongoing feedback related to quality issues.
- Sustain a clean and safe work area using 6S principles.
What you'll bring:
- Bachelor's degree in science or engineering required. Advanced degree in the life sciences, physical sciences or engineering preferred.
- Minimum of 5 years of quality experience in pharma, med
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