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Company

GE HealthCare · 5 hours ago

QA Leader - PET

United States

Full-time

Remote

Mid, Senior Level

$99K/yr - $148K/yr

3+ years exp

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Growth Opportunities

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Responsibilities

Managing the quality relationship through set up and continuous oversight of multiple third party manufacturing sites to achieve consistent product quality and compliance to applicable regulatory requirements

Conducting reviews, performing audits, clearly documenting findings and identifying risk across the PET Global Supply Chain

Clearly communicating audit results and recommendations

Providing follow up activities to internal and external audits including: identifying root cause, assessing risk and providing direction on potential resolution.

Supporting routine internal QA operating mechanisms to ensure compliance and continuous improvement of the supply chain and quality management system

Supporting activities related to product registrations and regulatory processes

Representing QA on technology transfer and product / process improvement projects

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality AssuranceRegulatory AssuranceCertified AuditorLead AuditorPharmaceutical IndustryGMP InspectionsISO InspectionsRadiopharmaceuticalsMedical DevicesProcess ImprovementSupervisory ExperienceCompliance Issues

Required

Bachelor's degree in a Scientific, Engineering, Computer Science, core Life Science discipline, or a combination of training and experience demonstrating the equivalent

3+ years of Quality Assurance/Regulatory Assurance experience in the pharmaceutical industry

Supervisory/management experience

Preferred

Certified Auditor or Lead Auditor

Experience working in remote teams and with people in different countries

Knowledge and experience of the manufacture of radiopharmaceuticals and /or medical devices

Experience hosting and /or responding to regulatory GMP or ISO inspections

Strong track record of identifying and fixing compliance issues

Strong process improvement mindset, passion for quality

Benefits

Medical

Dental

Vision

Paid time off

A 401(k) plan with employee and company contribution opportunities

Life

Disability

Accident insurance

Tuition reimbursement

Company

GE HealthCare

Glassdoor

4.2

GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees