Investigation Lead II

Zvh; United States; Sur place; USD 88 000 - 121 000; Plein temps

Avantages offerts par ce poste

Medical and dental coverage starting 1

401(k) with company matching

Paid time off (20–35 days)

Résumé du poste

Baxter is seeking a Quality Investigation & CAPA Lead to drive investigations from intake to resolution, evaluate evidence, and determine root causes with cross-functional partners. You will ensure timely, risk-based decisions that protect patients and customers.

The role requires strong analytical thinking, technical judgment, and collaboration skills, with experience in eQMS systems and writing inspection-ready reports. Join a purpose-driven team delivering high-quality healthcare solutions.

Qualifications

• Bachelors degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or an equivalent regulated-industry background.
• 3+ years in pharmaceutical/biotech/medical device quality ops in a regulated environment.
• 2+ years leading or contributing to investigations, deviations, or CAPA programs.
• Working knowledge of cGMP, GDP, investigation processes, CAPA, and data integrity expectations.
• Ability to evaluate evidence objectively and develop defensible, data-based conclusions.
• Strong technical writing, project management, and communication skills.

Responsabilités

• Lead quality investigations from intake through completion with risk-based evaluation of events.
• Analyze manufacturing records, lab data, interviews, and reports to identify findings and conclusions.
• Develop and test hypotheses to determine root and contributing causes using structured methods.
• Collaborate with Quality, Manufacturing, Engineering, Lab Ops and others to gather evidence and drive solutions.
• Assess potential product, process, compliance and patient impacts with risk evaluations and dispositions.
• Recommend CAPAs addressing causes with measurable effectiveness indicators and ensure inspection-ready reports.

Connaissances

Quality investigations

Root cause analysis

Data-driven decisions

Cross-functional collaboration

Formation

Bachelors degree in Science, Engineering, Pharmacy, Life Sciences, Quality

Outils

TrackWise

Microsoft Office

eQMS

Description du poste

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

As a Quality Investigation & CAPA Lead, you will serve as a key driver of quality excellence, leading investigations from initial assessment through completion and approval. You will evaluate evidence, challenge assumptions, test potential causes, and partner with cross-functional experts to determine the most effective path forward. Your work will directly influence product quality, regulatory compliance, and operational performance by ensuring investigations are thorough, objective, timely, and inspection-ready. Success in this role requires strong analytical thinking, technical judgment, collaboration skills, and a commitment to making data-driven decisions that protect patients and customers.

What You'll Be Doing

• Lead quality investigations from intake through completion, ensuring timely, risk-based evaluation of quality events, deviations, complaints, or nonconformances.
• Analyze evidence from manufacturing records, laboratory data, interviews, process observations, and technical reports to identify findings and support objective conclusions.
• Develop and test multiple hypotheses to determine direct, contributing, and root causes using structured investigation and problem-solving methodologies.
• Partner with subject matter experts across Quality, Manufacturing, Engineering, Laboratory Operations, and other functions to gather evidence, align on findings, and drive effective solutions.
• Assess potential product, process, compliance, and patient impacts while supporting appropriate risk evaluations and disposition decisions.
• Recommend corrective and preventive actions (CAPAs) that address identified causes, prevent recurrence, and include measurable indicators of effectiveness.
• Author clear, concise, inspection-ready investigation reports and maintain complete documentation within the electronic Quality Management System (eQMS).

What You'll Bring

Required Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline, or an equivalent combination of education and directly relevant regulated-industry experience.
• 3+ years of experience within pharmaceutical, biotechnology, medical device, manufacturing, laboratory, engineering, or quality operations in a regulated environment.
• 2+ years of experience leading or significantly contributing to formal investigations, deviations, nonconformances, customer complaints, or CAPA programs.
• Working knowledge of cGMP requirements, Good Documentation Practices, investigation processes, CAPA principles, quality risk management, and data integrity expectations.
• Demonstrated ability to evaluate evidence objectively, perform root cause analysis, and develop defensible, data-based conclusions.
• Strong technical writing, problem-solving, project management, facilitation, and communication skills.
• Experience working with electronic Quality Management Systems (eQMS), such as TrackWise, and Microsoft Office applications.

Preferred Qualifications

• Experience supporting FDA, Health Canada, customer, or other regulatory inspections and audit activities.
• Knowledge of structured problem-solving methodologies including 5 Whys, Fishbone/Ishikawa Analysis, DMAIC, Fault Tree Analysis, or similar approaches.
• Experience using reporting, visualization, or statistical analysis tools to identify trends and support decision making.
• Lean Six Sigma Green Belt, ASQ certification, or equivalent quality and process improvement credentials.
• Experience working in pharmaceutical, biotechnology, or medical device manufacturing environments with complex quality systems.

Compensation

At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000 - $121,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

US Benefits at Baxter (except for Puerto Rico)

• 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.

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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.