Global PV QA Auditor: Elevate Compliance & CAPA Effectiveness

GE HealthCare (United States); Oregon; Hybrid; USD 102,000 - 153,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

401(k) plan with company match

Life insurance

Disability insurance

Tuition reimbursement

Job summary

GE HealthCare is seeking a QA Auditor focused on Pharmaceutical Diagnostics (PDx) with emphasis on PV QA and GMP site oversight. The role involves auditing, regulatory support, and ongoing compliance improvements across global PV processes.

Candidate should have 6+ years in pharma, auditing experience, and ability to navigate MHRA, FDA and EMEA guidelines. This position is based in the United States with potential incentive compensation per company policy.

Qualifications

• Experience auditing within pharmaceutical manufacturing or PV processes.
• Ability to interpret and apply regulatory requirements (MHRA, FDA, EMEA).
• Experience interfacing with global regulatory agencies is required.
• Strong communication and problem-solving skills.

Responsibilities

• Plan, prepare and execute internal and external audits for QRA.
• Remediate identified actions and ensure timely closure for effectiveness.
• Conduct risk analysis of systems and processes with customers.
• Support regulatory inspections and customer audits as QA SME.

Skills

Auditing experience

Regulatory know-how

Global regulatory interfacing

Communication skills

PV QA knowledge

Education

Bachelor's degree

High school diploma + 8 years pharma exp

Job description

GE HealthCare is seeking a QA Auditor focused on Pharmaceutical Diagnostics (PDx) with emphasis on PV QA and GMP site oversight. The role involves auditing, regulatory support, and ongoing compliance improvements across global PV processes.

Candidate should have 6+ years in pharma, auditing experience, and ability to navigate MHRA, FDA and EMEA guidelines. This position is based in the United States with potential incentive compensation per company policy.