Quality Investigation Lead - CAPA & Risk Expert

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

Benefits dieser Stelle

Medical and dental coverage

401(k) with company match

Employee stock purchase plan (ESPP)

Paid time off 20–35 days

Zusammenfassung

Baxter seeks a Quality Investigation Lead to manage investigations from initiation through completion within our Quality-led program. You will apply structured problem-solving, evaluate evidence, and drive risk-based decisions to resolve quality events ensuring patient safety and operational excellence.

You will collaborate with cross-functional experts to assess product impact, recommend CAPAs, and maintain complete investigation records in the eQMS, contributing to continuous quality

Qualifikationen

• Bachelor’s degree in a technical field or equivalent regulated-experience.
• 3+ years in pharma/biotech/medical devices with quality operations.
• 2+ years leading investigations, deviations, CAPAs, or related processes.
• Knowledge of cGMP, GDP, quality systems and data integrity.
• Proven ability to evaluate evidence and perform root cause analyses.
• Strong writing, project management, and cross-functional communication.

Aufgaben

• Lead quality investigations for deviations, complaints, and events with timely execution.
• Analyze data across manufacturing, labs, and quality systems to build conclusions.
• Develop multiple hypotheses and determine root and contributing causes.
• Assess impact on products, processes, data, and patients for risk decisions.
• Collaborate with SMEs to gather evidence and drive investigation plans.
• Recommend CAPAs addressing causes to reduce risk and improve processes.
• Create inspection-ready reports and maintain records in the QMS.

Kenntnisse

Quality investigations

Root cause analysis

Problem solving

Technical writing

Cross-functional collaboration

Ausbildung

Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality or related field

Tools

TrackWise

Microsoft Office

eQMS (general)

Jobbeschreibung

Baxter seeks a Quality Investigation Lead to manage investigations from initiation through completion within our Quality-led program. You will apply structured problem-solving, evaluate evidence, and drive risk-based decisions to resolve quality events ensuring patient safety and operational excellence.

You will collaborate with cross-functional experts to assess product impact, recommend CAPAs, and maintain complete investigation records in the eQMS, contributing to continuous quality