OE & Metrology Analyst

The OE and Metrology Analyst will play a pivotal role in Supporting electronic system administration of OE team supporting electronic system administration (LIMS and Empower), Instrument life cycle management including but not limited to setting up new instrument and electronic system management, performing calibrations and maintenance. Lab admin for QC instruments and E-System. Writing and revising documents for the QC department including, but not limited to, SOPs, AMPs, protocols, reports, and other technical documents. Supporting QC operations, including but not limited to samples, reference standard regulatory retains and stability samples management, training management, document management and procurement, QC budget management and proposal management within Germany QC at WuXi Biologics. Testing samples including, but not limited to, water samples and production samples (bioburden, endotoxins, conductivity, TOC, etc.), and performing the related documentation of the tests and the results.

Department Description

As OE and Metrology Analyst, you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the Lead of Metrology.

• Sample management, including receiving, inventory, storage, distribution and disposition of samples, reference standard, regulatory retains, stability samples, etc.
• Responsible for managing QC relevant proposals, including providing QC prices, updating QC prices and so on
• Supporting QC procurement, including purchase, receiving, and invoice conformation
• Manage inventory of reagents and consumables
• Manage and track the schedule of metrology activities and ensure that the calibration and maintenance is carried out on time
• Lab administrator for E-System like: Empower, LIMS and QC instruments
• Troubleshoot the instruments and electronic system as required
• Review SOP/ protocol/ report related to Metrology/ OE
• Responsible for quality events related to OE, Metrology and electronic systems such as deviation, OOS, CC

Qualifications

• Graduation as technical assistant, Bachelor degree, Master degree or comparable degree in microbiology, biochemistry, molecular biology, chemistry or another comparable field

Knowledge/Experience

• Knowledge in GMP requirements of EMA, FDA and other relevant standards, e.g. ICH or WHO
• Experience with Instrument management
• Experience in microbiology
• Strong technical knowledge of Metrology and electronic system
• Familiar with sample and reference standard management workflow
• Good communication skills in Englisch and German (written and spoken)
• Familiar with training, document management and procurement workflow would be beneficial

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!

Would you like to know more before you apply? Please visit us at Biologics is an equal opportunities employer.