Capa Jobs (NOW HIRING)

This is whereyour 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.

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.

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

• 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.

• 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.

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.

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