Posted on: April 8, 2021
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.-SummaryThe
Quality Auditor monitors implementation and compliance with the
requirements established by the Plant's Quality System by
performing internal audits.- This position interacts directly with
Client auditors and Regulatory inspectors and also participates in
activities hosting client audits and regulatory inspections. This
position reports to the Manager I, Quality Compliance.Essential
Duties and Responsibilities (these are primary responsibilities of
the role and the incumbent will perform other duties as
- Performs internal audits / assessments by collecting and
analyzing objective evidence regarding issues and risks. Ensures
that audit schedules are produced and communicated in a timely
- Plans, schedules, coordinates, supports, and leads detailed
audits of facility practices to ensure that policies and procedures
comply with worldwide regulatory agencies and Corporate Quality
Policy guidelines. -This includes review of updated GMP regulations
and current FDA and outside of US requirements and incorporation
into internal programs, where appropriate.
- Leads/supports Client audits of the facility. Prepares for the
audit/assessment activity by researching background information,
including previous audit results. Assists in reviewing audit
responses.- Maintains the assessment file through the process to
- Supports routine GMP and Pre-Approval Inspection regulatory
audits.- Prepares for audits by coordinating documentation,
arranging facility tours, reserving conference rooms, and
communicating with facility subject matter experts.- May interface
with regulatory inspectors during audits.
- Evaluates corrective and preventive action responses to
assessment findings for adequacy, including root cause and
- Conducts and confirms follow-up actions on Corporate, Client,
Internal, and Regulatory site compliance audits/inspections.
Reports extended corrective actions to management.
- Performs procedure gap assessments to ensure compliance with
Global Quality procedures.
- Maintains and makes recommendations for improvement to Quality
- Performs desktop evaluations of site's suppliers per Global
- Bachelor's degree required, preferably in a scientific or
- Minimum 3 years experience in the pharmaceutical/biotech
- Previous auditing experience preferred; ASQ CQA and/or RAB
auditor accreditation is desired.
- Computer proficiency in Microsoft Word, Excel, and Outlook and
the ability to use enterprise software (examples include:- JDE,
BPLM, Pilgrim, Trackwise, etc.)Physical / Safety Requirements
- Must be able to gown qualify for Grade C/D production
- Duties may require overtime work, including nights and
- Use of hands and fingers to manipulate office equipment is
- Position requires sitting for long hours, but may involve
walking or standing for periods of time#LI-LH1#IND-USOPSEqual
Employment OpportunityBaxter 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
Reasonable AccommodationsBaxter is committed to working with and
providing reasonable accommodations to individuals with
disabilities. If, because of a medical condition or disability, you
need a reasonable accommodation for any part of the application or
interview process, please send an e-mail to Americas_TTA@baxter.com
and let us know the nature of your request along with your contact
Keywords: BAXTER, Bloomington , Quality Auditor, Accounting, Auditing , Heltonville, Indiana
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