Quality Investigator II: CAPA & Compliance Advocate

Milwaukee Succeeds; Round Lake (IL); Sur place; USD 88 000 - 121 000; Plein temps

Avantages offerts par ce poste

Medical and dental coverage

ESPP with stock purchase at discount

401(k) with company match

Paid time off 20–35 days

Parental leave

Commuting benefits

Employee discounts

Employee Assistance Program

Résumé du poste

Baxter seeks a Quality Investigator to lead investigations into deviations, nonconformances, complaints, and other quality events across manufacturing and quality systems. You will analyze data from manufacturing, labs, and engineering to identify facts, evaluate evidence, and develop defensible conclusions.

Collaboration with cross-functional teams drives CAPAs and product disposition decisions. Strong technical writing, project management, and knowledge of eQMS (TrackWise or similar) are

Qualifications

• Bachelor’s degree in a scientific or quality discipline or related regulated-industry experience.
• 3+ years in pharmaceutical/biotech/medical device quality operations.
• 2+ years leading investigations, deviations, CAPAs, or complaints.
• Working knowledge of cGMP, DQP, QMS, and data integrity.
• Strong ability to evaluate evidence and develop defensible conclusions.
• Excellent written communication, project management, and problem solving.

Responsabilités

• Lead quality investigations for deviations, nonconformances, complaints, and other events.
• Analyze manufacturing, lab, engineering, and quality-system data to identify facts and conclusions.
• Develop hypotheses to determine root causes and contributing factors.
• Assess impact to products, processes, data, and patients, guiding decisions.
• Collaborate with cross-functional SMEs to gather evidence and drive CAPA plans.
• Recommend CAPAs addressing root causes and long-term improvements.
• Create inspection-ready investigation reports in eQMS.

Connaissances

Quality investigations

Root cause analysis

cGMP compliance

Data integrity

Technical writing

Project management

Cross-functional collaboration

eQMS knowledge

Communication of risks

Formation

Bachelor's in Science/Engineering/Pharma/Life Sciences

Outils

TrackWise

Microsoft Office

Description du poste

Baxter seeks a Quality Investigator to lead investigations into deviations, nonconformances, complaints, and other quality events across manufacturing and quality systems. You will analyze data from manufacturing, labs, and engineering to identify facts, evaluate evidence, and develop defensible conclusions.

Collaboration with cross-functional teams drives CAPAs and product disposition decisions. Strong technical writing, project management, and knowledge of eQMS (TrackWise or similar) are