OE & Metrology Associate Analyst

Teil I Primäres Ziel der Stelle / Part II Primary Job Objective

1. Supporting electronic system administration of OE team
   
   


2. Supporting electronic system administration (LIMS and Empower)
   
   


3. Instrument life cycle management including but not limited to setting up new instrument and electronic system management, performing calibrations and maintenance.
   
   


4. Lab admin for QC instruments and E-System
   
   


5. Writing and revising documents for the QC department including, but not limited to, SOPs, AMPs, protocols, reports, and other technical documents
   
   


6. 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.
   
   


7. 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*

*Testing is prohibited when the employee is assigned as laboratory/instrument administrator

Teil II Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

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


• Knowledge in GMP requirements of EMA, FDA and other relevant standards, e.g. ICH or WHO


• Experience with Instrument management


• Experience in microbiology

Besondere Kenntnisse / Special Knowledge

• 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

Teil III Berufliche Verantwortung / Part IV Job Responsibilities

1. Sample management, including receiving, inventory, storage, distribution and disposition of samples, reference standard, regulatory retains, stability samples, etc.

2. Responsible for managing QC relevant proposals, including providing QC prices, updating QC prices and so on

3. Supporting QC procurement, including purchase, receiving, and invoice conformation

4. Manage inventory of reagents and consumables

5. Manage and track the schedule of metrology activities and ensure that the calibration and maintenance is carried out on time

6. Lab administrator for E-System like: Empower, LIMS and QC instruments

7. Troubleshoot the instruments and electronic system as required

8. Review SOP/ protocol/ report related to Metrology/ OE

9. Responsible for quality events related to OE, Metrology and electronic systems such as deviation, OOS, CC