Quality Associate III (Fill/Pack)
Posted on: May 28, 2023
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
- 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
- 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
- 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
- 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
- Bachelor's degree in science or engineering required. Advanced
degree in the life sciences, physical sciences or engineering
- 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
- Good interpersonal/communication/influencing/negation
- Good project management skills
- Working knowledge of FDA Regulations, Application of Good
Laboratory Practices, and Application of Good Manufacturing
- Understand verbal and written safety and quality instructions
and read and comprehend written work instructions including words
- 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 , Marion, North Carolina
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