CAPA Investigator

Baxter International Inc.•Jayuya, PR

About The Position

As a CAPA Investigator, you will play a critical role in driving quality and compliance across the organization. You will work collaboratively with cross-functional teams to investigate quality events, identify root causes, develop effective corrective and preventive actions, and ensure compliance with applicable regulatory and quality system requirements. This role serves as a key contributor to continuous improvement initiatives and supports operational excellence throughout the product lifecycle.

Requirements

Bachelor's degree in Science, Business Administration, or a related discipline with 3–5 years of relevant experience, or a Master's degree with a minimum of 3 years of experience.
Experience leading investigations, CAPA processes, non-conformance management, or quality systems within a regulated industry.
Strong understanding of root cause analysis methodologies and investigation tools.
Demonstrated analytical and problem-solving skills with the ability to develop innovative approaches to investigations.
Excellent technical writing, documentation, and report-generation skills.
Strong interpersonal, communication, influencing, and negotiation abilities.
Ability to interpret technical procedures, regulations, specifications, and business requirements.
Fully bilingual in English and Spanish, with the ability to read, write, speak, and present effectively in both languages.
Proficiency with electronic quality management systems such as TrackWise 8.
Ability to collaborate effectively within cross-functional teams and build strong working relationships across all organizational levels.

Responsibilities

Own and lead CAPA investigations from initiation through completion, ensuring compliance with company procedures and regulatory requirements.
Develop and execute investigation plans, including defining scope, timelines, data requirements, and investigation methodologies.
Present investigation plans, findings, and recommendations during stage-gate reviews and management meetings.
Apply structured problem-solving methodologies and investigation tools to identify root cause(s) and contributing factors.
Determine and evaluate appropriate data sources, gather required information, and analyze data to support investigation conclusions.
Assemble and lead cross-functional investigation teams to ensure timely and effective execution of investigation activities.
Verify and support implementation of corrections and containment activities based on investigation outcomes.
Document investigation results clearly, accurately, and in accordance with CAPA and non-conformance procedures.
Partner with CAPA owners and stakeholders to develop corrective and preventive action plans and associated effectiveness plans.
Define effectiveness measures, acceptance criteria, and monitoring periods to evaluate action effectiveness.
Maintain complete, accurate, and current investigation records throughout the CAPA lifecycle.
Prepare technical reports, executive summaries, impact assessments, investigation plans, and final investigation reports.
Support Change Control Board (CCB/CRB) reviews related to CAPA activities and quality system improvements.
Coordinate meetings, teleconferences, and communications with internal departments and manufacturing facilities as required.
Serve as a subject matter expert during internal and external audits and regulatory inspections.
Ensure compliance with applicable regulations and standards, including cGMP, QSR, GLP, USP, FDA requirements, and company quality procedures.
Perform data entry and management activities within the TrackWise 8 system and provide guidance to users regarding system workflows and transactional processes.
Manage multiple investigations simultaneously while meeting established timelines and quality expectations.
Communicate effectively with personnel at all organizational levels and work flexible schedules, including extended hours or weekends when business needs require.