Glp QA Associate
il y a 1 jour
To further strengthen our Quality team, we are looking for a motivated QA Associate with a quality mindset; to fulfill a temporary position of 6 months (maternity leave). This role can be filled through consultancy as well.
The GLP QA Associate will play a role in further build out of R&D quality infrastructure at argenx in close collaboration with internal business teams.
**Key accountabilities and responsibilities**:
The role is responsible for performing duties related to quality review of GLP-compliant plans and reports, working in close collaboration with the argenx PharmToxBA team and Non Clinical & BioAnalytics Quality Lead:
- Review of experiments in electronic Lab Notebook
- Review of study plans and reports (both internal and external)
- Qualification of vendors, including animal welfare check
- Follow up of quality issues (deviations, CAPAs)
- Ensure Quality goals are met and all practices and procedures comply with company policies and applicable regulations
- Support the further build-out of quality processes and systems within R&D
The role may also support the QA team with additional ad hoc project support.
**Desired skills and experiences**:
- 3y+ experience in a quality assurance role, dealing with biopharmaceuticals with experience in biological analytical methods.
- Experience with GLP OECD guidelines.
- Quality attitude; can do mentality;
- Good organization and planning skills;
- Strong communication skills and able to build relationship with business partners and to work effectively together with others
- Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines.
- Fluent in English - our working language.
**Offer**:
- A competitive salary package with extensive benefits
- Front seat in the development of therapeutic antibodies
- A work environment in a human-sized, dynamic and rapidly growing biotech company