Auditor, Quality

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Your Role at Baxter

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Auditor, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What we offer from day 1

• Medical, Dental, Disability and Life Insurance coverage

• Vision Plan

• Paid Vacation Days and Paid Holidays

• Paid Parental Leave

• Retirement Plan 165e

• Employee Stock Purchase Program

• Educational Assistance Plan

What you'll be doing

• Leads internal audit program and readiness for the external inspections. Conduct assessments adhering to the approved internal audit schedule using the applicable Baxter Quality Manual, division and/or local procedures, applicable regulations, standards, inspection guidelines and compendial requirements.

• Lead the planning and development of assessment strategy and logistics for Internal and External Audits. Coordination and execution of the yearly audit schedule.

• Conduct audits/assessments by researching background information, including previous internal/external audit results, applicable regulations and standards as well as local and global standard operating procedures. Collect and analyze objective evidence regarding issues and risk; report findings (verbally and written) to management.    

• Audit System Management Review presentation.

• Evaluate observations responses and CAPA action plan for adequacy, including risk impact, root cause, timeliness and effectiveness.

• Maintain audit file through the process up to audit closure. TrackWise 9 local internal audit system administrator.

• Assess, assign and assure completion for the Global Observation Certification Program gap assessments.

• Liaison between Regulatory and Guayama Plant regarding external inspections and submission requests.

• Assure the facility is audit ready at all times.

• Annual Product Review (APR) Coordination, compilation and submission in TCU system.

• Update MOST scorecard, PRO Site Model scorecard, among others.

• Assist in the execution of other programs such as Certification of Document Review (CDR), Regulatory Requests, contingency documentation and cGMP training for new hires, temporary personnel or contractors.

What you'll bring

• Fully Bilingual - written and spoken English and Spanish

• Strong cGMP knowledge, 21 CFR Part 11, 210 and 211, ICH Q7A, Eudralex and other applicable to API and FG anesthetics.

• Professional License or Certification Required: Lead Auditor Certification

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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.