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Full 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:
Conducts external and
internal compliance audits ensuring compliance with all applicable
processes, systems and provisions of the Quality System, including
regulatory requirements. Serves as a technical expert within the
Quality Compliance department. Is responsible for results in terms of
quality system conformance to regulations and Baxter quality policies.
What you’ll do:
- Prepare for Internal and
Client audits by researching background information, including
previous audit results. - Perform internal audits by
collecting and analyzing objective evidence regarding issues and
risks. Report findings to management team. - Host routine
audits conducted by the company’s contract manufacturing clients which
includes escorting business guests during facility tour, coordinating
document review and arranging subject matter expert interviews. - Evaluate corrective and preventive action responses to the
assessment findings for adequacy, including root cause and timeliness.
Communicate issues to management team. - Manage the tracking,
reporting, positioning, adequacy of actions, verification, closeout,
and trending of audit-related corrective and preventive actions. - Manage the assessment file through the process to closure.
- Perform follow-up audits to confirm corrective and preventive
action is effective. - Remain current in regulatory knowledge
through attendance at related conferences, seminars, meetings, and
other training methods such as independent study of periodicals,
Internet or other literature. - Support and participate with
management during external regulatory and corporate inspections as
needed. - Conduct and report on gap assessments against
regulations, regulatory findings, and Corporate procedures. - Perform supplier quality responsibilities as applicable to
local site. - Perform Quality approval and Periodic Review for
Standard Operating Procedure revisions that impact Quality Compliance - Extensive working knowledge of applicable quality and
regulatory standards and regulations. Expertise in global GMP
regulations. - Excellent communication skills – both written
and oral. - Work effectively independently and in team
environment. - Must demonstrate sound judgment,
problem-solving, and analytical skills to enable assessment of risk.
Experience with risk management and root cause analysis preferred. - Strong courage of conviction, conflict resolution,
interpersonal and influencing skills. - Ability to establish
relationships across functional boundaries at multiple levels
internally/externally. - Ability to demonstrate strong
organizational and project management skills. - Good working
knowledge of Windows based applications. - Resourceful,
self-reliant, self-motivated and confident. - Working knowledge
of quality software system (e.g. TrackWise). - General
knowledge of Lean Six Sigma and other continuous improvement tools.
What you’ll bring:
- Bachelor’s degree
(Science or Engineering preferred) - 3-5 years of Quality,
Compliance, Manufacturing, Engineering or Technical Services
experience. - Quality auditing experience in cGMP environments
with particular experience in aseptic manufacturing environments
preferred. - Independent auditor certification preferred (e.g.,
ASQ CQA, RAPS RAC, or ISO lead auditor.
The physical
requirements:
- Must be able to gown for Grade C
areas. - Position requires sitting, standing, and walking for
long periods of time, squatting/bending, lifting up to 25 pounds,
navigating mechanical spaces and stairs. - Duties will require
overtime work as needed. - Use of hands and fingers to
manipulate office equipment is required.
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 $52,800
to $132,000 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.
#IND-USOPS
#LI-LH1
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 .
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