Sr. Quality Technical Auditor
Req #: 18000F8L_en
Location: Round Lake, IL US
Job Category: Quality
Date Posted: 10/16/2018 2:20:06 PM
Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You'll find Baxter's products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter's employees are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
Responsible for supporting Baxter's Global Internal Audit/ Audit Readiness program. Ensure compliance to company policies, regulations and global standards.
Essential Duties and Responsibilities
Performs Quality Management System compliance audits as a team member and/ or lead as required.
Interacts with all levels of internal management across functions and business units
Communicates results of audits and internal control evaluations in reports and presentations
Evaluates audit responses for adequacy, including root cause, timeliness as well as utilizes knowledge to facilitate appropriate corrective action
Resolves complex issues and escalates concerns through business and Quality management
Serves as a cGMP consultant/ subject matter expert and provides researched and supported opinions to complex compliance issues
As needed, participates in and/ or supports preparation of regulatory agency inspections and/ or responses to external observations
Maintains all organizational and professional ethical standards, while actively advocating and monitoring compliance
Actively supports continuous improvement of the audit program and Global Compliance
Participates in special projects as needed
Acts as a mentor/ coach to guest auditors and new hires
Thorough knowledge of applicable Global regulations and standards
Must be willing to travel up to 50% both domestically and internationally
Excellent verbal and written communication skills, including presentation skills
Strong courage of conviction, conflict resolution, interpersonal and influencing skills
Strong technical, analytical, judgment and problem solving skills
Ability to build relationships across functional boundaries at multiple levels internally and externally
Ability to independently make quick, sound decisions with limited data and execute appropriate judgment on when to escalate information
Ability to be self-motivated and work independently within defined timelines
Education and Experience
Bachelors Degree in Science or Engineering
Minimum of 7+ years of experience in Quality, Compliance, Manufacturing, Engineering or related field
5 years of management experience
Independent Certifications desired (e.g. CQA, RAPS)
Experienced FDA Auditor is a requirement
A Career That Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
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
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.