Quality Assurance Officer

  • Location: BEERSE
  • Type: Contracting
  • Job #17417

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Quality Assurance Officer

This role is situated within the eLIMS Center of Excellence, and independently creates, updates and maintains high quality Master Data within eLIMS, integrates instruments and applications within eLIMS, performs user acceptance testing and translates specifications within the eLIMS system by utilizing current business processes.

You are someone who takes ownership by completing any incoming requests in a timely manner. You escalate any issues and understand the impact towards other customers when changing/updating existing Master Data. To maintain high quality data, you collaborate with customers to fully understand the Master Data requirements and will review all configurations for accuracy and completeness.

In this role you mentor, lead, and train team members.

You collaborate with multiple internal customers (e.g. Large molecule, Small Molecule, Research and Development…) to fully understand the Master Data requirements and will review all configurations for accuracy and completeness.

In this role you are able to lead small projects within the Center of Excellence, e.g. Harmonization/standardization of processes.

Scope of work:

  • 75 – 85 % – creating, updating, reviewing & approving Master Data including worksheet templates, worklist templates and sample plans, specifications
  • 10 – 20% – Maintaining system related documentation (procedures, events, etc) with the appropriate applications (Docspace, Trackwise, Clearquest, Q-Test or any other designed system; Participating in system related project activities as requested by the CoE lead including review and testing of system updates
  • Coordinating eLIMS activities with the local labs; Updates eLIMS instrument master data, eLIMS Empower master data, eLIMS LES master data and uploads Smart QC Master Data
  • Creating test scripts for user acceptance testing, and executes user acceptance testing using customized test scripts from the local labs
  • Participating in capability development activities according to training requirements
  • Provide feedback to CoE team lead regarding eLIMS activities performance
  • 5 % – Provide feedback to CoE team lead regarding eLIMS activities performance

Who are you?

  • A Bachelor's degree or equivalent education is required. You have 3 – 5 years of experience. Knowledge & experience with LIMS is required
  • You can manage multiple issues, organize activities, prioritize, and escalate to management when appropriate. They must be precise and accurate on the data they are managing
  • You have broad knowledge and experience with cGMPs, regulations, risk management. Previous Quality Systems experience is required
    • Knowledge of/familiarity with other appropriate lab systems (Empower/SDMS/LES) is a plus
  • You have decent written and verbal communication skills (At least English – B2).
  • You have experience working in a pharmaceutical or another highly regulated industry. Experience with quality assurance, quality control, analytical testing or IT is a plus
  • You are flexible to adapt to urgent needs
  • You have the ability to interact with Local lab leaders where necessary regarding master data related issues. They must have the ability to maintains strong relationship with Local Labs and maintain a clear line of communication with the eLIMS CoE lead. They must have a strong customer focus and be dedicated to meeting customer expectations as determined by the CoE lead. 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

 

Are you interested? Apply now with your cv!

 

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