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Document Control Specialist / QA Associate

Workscope: Quality Management

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Juno Therapeutics GmbH is an innovative German subsidiary of a fast-growing American biotechnology company in the field of adaptive cell therapy (www.junotherapeutics.com) with headquarters in Munich. Our goal is to develop new immunotherapies for the treatment of tumors. For our office in Goettingen, we are looking for a full-time
 
Document Control Specialist / QA Associate

with a fixed-term contract for 2 years.

Job Summary

The primary focus of the Document Control Specialist/QA Associate is to assist with our QM system and controlling of all documentation around the batches we currently produce for documents and records for clinical and commercial products.  
The key deliverables for this role will be to establish document control processes for managing the Juno Manufacturing Plant sites documents and records.  This position will generate and manage all aspects of the documents life cycle.
 

Primary Responsibilities
  • Assist with the development and building of the Document Control process at Juno Therapeutics for the control of GxP related documents and records.
  • Process new and revised Juno Therapeutics procedures, forms, Specifications, and other cGMP documents via approved Document Change Control process.
  • Establish document control templates and consistency practices for generation of controlled effective documents and records.
  • Establish a process for Batch Record issuance, control and reconciliation
  • Assist with Label issuance, control and reconciliation
  • Issuance, tracking and completion of Document Change Controls; including formatting and review of documents for adherence to document control standards.
  • Update of Area Reference Binders upon creation or revision of controlled documents.
  • Assist with the implementation of an Electronic Document Management System (EDMS).
  • Data entry for tracking and trending of document review lifecycle.
  • Data entry for tracking and trending training records for employees at the site.
  • Scanning, filing, and retention of all cGMP documents at the site.
  • Preparing documents for off-site archival.
  • Facilitate periodic review of controlled documents.
 
Required Qualifications
  • Experience in Document Control.
  • Experience designing and building processes and writing standard operating procedures.
  • Some working knowledge of Good Tissue Practices (21 CFR 1271) and Good Manufacturing Practices (21 CFR 210/211, 600, & 820).
 
Education Requirements
  • A bachelor’s degree with 5+ years of QA industry experience  OR
  • 7+ years of relevant experience in a regulated environment.
 

Contact detail


How to apply:
Please send your application via email
Send application to
Ljudmila Hill
ljudmila.hill@junotherapeutics.com

Job profile


Working hours
Full-Time
Contract duration
Temporary
Type of job
Specialist
Work experience
jobexperience is required
Region
Germany (Niedersachsen)
Working place
37079 Göttingen
Area of expertise
Biology & Life Sciences, Biotechnology, Pharmaceutics
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