Quality Investigations Lead & CAPA

Zvh; United States; Presencial; USD 88.000 - 121.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical and dental coverage starting 1

401(k) with company matching

Paid time off (20–35 days)

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality investigations

Root cause analysis

Data-driven decisions

Cross-functional collaboration

Educación

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

Herramientas

TrackWise

Microsoft Office

eQMS

Descripción del empleo

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.