CAPA Investigator

Baxter • Jayuya, PR

6d

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 Team 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.

Benefits

• Medical, Dental, Disability and Life Insurance coverage
• Vision Plan
• Paid Vacation Days and Paid Holidays
• Paid Parental Leave
• Retirement Plan
• Employee Stock Purchase Program
• Educational Assistance Plan
• health and well-being benefits
• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• 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
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level