Job Description Summary

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Product quality review associated with the manufacturing process. Accountable for the quality of own work. Subject to direct operations supervision/prescribed work instructions/systems checking. Executes within a well-defined operations framework. There is generally a step by step sequence of standard operational tasks which need to be followed to achieve an end result.

Roles and Responsibilities

• Manage the Micro equipment Preventative Maintenance schedule including Centron.

• Deputise for the Micro Technical Leader as required.

• Support Site operations wrt to Microbiological activities e.g Biohazard activities

• Support Batch release functions, specifically MBS release and IR progression

• Support EM associated cross functional IR’s and Investigations for QC.

• Complete quarterly trend reports/documentation for other team members on request.

• Audit support for Micro related queries and production

• Liaise with Utilities, Production/Engineering regarding escalations

• Support Sterilities Assurance activities/ yearly validation schedule.

• Contractor Management: Permits, RAMS, Induction, Annual Contracts and QA agreements,

• Maintenance of microbank cultures,

• Equipment PQR's,

• BI Stock Management: Ordering, Qualification, Contract Lab testing, Shelf life testing,

• Endotoxin challenge studies - vial washers and depyrogenation tunnels

• Qualifications and experience

• Degree (or equivalent) in Microbiology, or in a Science subject

• Familiar with Regulatory and ICH expectations of good laboratory practices, equipment qualification and maintenance.

• Familiar with QC systems and processes, especially LIMS, MODA & Veeva.

• Theoretical and practical knowledge of QC equipment qualification and maintenance.

• Experienced in data compilation, review and report generation

• Experienced in Data Integrity requirements for QC.

• Experience with Change Controls and Project Management - leading & oversight as well as contributory role.

• Familiar with Annex 1, ICH guidelines, PDA documents.

• Desirable skills

• Works in an organized manner

• Works independently and seeks solutions

• Clear thinker and disposed for troubleshooting

• Good understanding of how work of own team integrates with other teams

• Contributes when working in cross functional groups

• Maintains a latitude to rearrange the sequence to complete task/duties based on changing work situations

• Flexible, self-motivating, quickly familiarize themselves with new problems and responsible

• Team player who will actively engage with key stakeholders on site.

Inclusion and Diversity

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information

Relocation Assistance Provided: No