Auditor, Quality

Baxter•Guayama, PR

About The Position

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.

Requirements

Bachelor's degree in science or related field with three (3) to five (5) years' experience.
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

Responsibilities

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.