QC Micro Senior Analyst - 1 year fixed-term contract

at  GE Healthcare

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.

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.

• 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