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Auditor, Quality

https://www.baxter.com/ Logo

Baxter

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Location:
United States of America , Guayama

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility:

  • 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

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
What we offer:
  • 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
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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