Senior Quality Investigation Lead

Baxter International; Round Lake (IL); Vor Ort; USD 88.000 - 121.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental coverage

401(k) with company match

Paid time off (20–35 days)

Zusammenfassung

Baxter in Round Lake, IL is seeking a Quality Investigation Lead to manage investigations from initiation to completion, applying structured problem-solving, risk-based decisions, and objective evidence to determine causes and solutions.

You will collaborate with cross-functional experts, assess patient impact, propose corrective actions, and ensure records are inspection-ready within the eQMS. The role drives quality, safety, and operational excellence across the site.

Qualifikationen

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or related technical discipline.
• 3+ years of experience within pharmaceutical, biotechnology, medical device, manufacturing, engineering, laboratory, or Quality operations in a regulated environment.
• 2+ years of experience leading or contributing to investigations, deviations, nonconformances, or CAPAs.
• Working knowledge of cGMP regulations, Good Documentation Practices, quality systems, CAPA principles, quality risk management, and data integrity requirements.
• Demonstrated ability to evaluate evidence objectively, perform root cause analysis, and develop defensible conclusions.
• Strong analytical thinking, technical writing, project management, facilitation, interviewing, and problem-solving skills.
• Experience using Microsoft Office applications and electronic Quality Management Systems (eQMS) such as TrackWise or similar platforms.

Aufgaben

• Lead quality investigations for deviations, nonconformances, complaints, and other quality events, ensuring timely execution in accordance with risk-based quality processes and regulatory requirements.
• Analyze manufacturing, laboratory, engineering, and quality-system data to identify facts, evaluate evidence, and develop well-supported conclusions.
• Develop and test multiple hypotheses to determine direct, contributing, and root causes using proven investigation and problem-solving methodologies.
• Assess actual and potential impact to products, processes, data, and patients while supporting risk-based quality decisions and product disposition activities.
• Partner with cross-functional subject matter experts to gather evidence, resolve issues, drive alignment, and execute investigation plans.
• Recommend corrective and preventive actions (CAPAs) that address identified causes, reduce risk, and support long-term process improvement.
• Create clear, thorough, and inspection-ready investigation reports while maintaining accurate records within the electronic Quality Management System (eQMS).

Kenntnisse

cGMP regulations

Root cause analysis

Risk assessment

Documentation

Problem solving

Cross-functional collaboration

Analytical thinking

Ausbildung

Bachelor's degree in Science/Engineering/Pharmacy/Life Sciences

Tools

TrackWise

Microsoft Office

Jobbeschreibung

Baxter in Round Lake, IL is seeking a Quality Investigation Lead to manage investigations from initiation to completion, applying structured problem-solving, risk-based decisions, and objective evidence to determine causes and solutions.

You will collaborate with cross-functional experts, assess patient impact, propose corrective actions, and ensure records are inspection-ready within the eQMS. The role drives quality, safety, and operational excellence across the site.