Quality Associate III (Fill/Pack)

Company: BAXTER
Location: Asheville
Posted on: May 28, 2023

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: Successfully 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. 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 where appropriate, 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, medical device or related field
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation.
  • Understanding of Label Copy Control, as well as change control processes.
  • Good interpersonal/communication/influencing/negation skills.
  • Good project management skills
  • Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
  • Must have basic English written and oral communication skills adequate to communicate with other team members. 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 $68,000 to $156,000 and also includes an annual incentive bonus. 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. Other Duties as Assigned Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required. 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 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 . 096190

Keywords: BAXTER, Asheville , Quality Associate III (Fill/Pack), Other , Asheville, North Carolina