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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxters 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.

Summary

The Quality Auditor monitors implementation and compliance with the requirements established by the Plants 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 assigned)

* 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 fashion.
* 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 closure.
* 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 timeliness.
* 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 procedures.
* Performs desktop evaluations of sites suppliers per Global Quality procedures.

Qualifications

* Bachelor's degree required, preferably in a scientific or technical discipline.
* Minimum 3 years experience in the pharmaceutical/biotech industry.
* 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 areas.
* Duties may require overtime work, including nights and weekends
* Use of hands and fingers to manipulate office equipment is required
* Position requires sitting for long hours, but may involve walking or standing for periods of time

LI-LH1

IND-USOPS

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. 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 information.