QA Associate
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Leiden • Netherlands
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About the role
- Quality point of contact for cell and gene laboratories at Leiden and their contract laboratories.
- Acts as Quality Subject Matter Expert (SME) for assigned quality processes and/or analytical techniques ensuring an appropriate quality and compliance level by applying risk management in line with the intended use and phase of development.
- Establish and develop cooperative working relationships within and across the cell and gene laboratories, CSQ, global quality organization, including single quality voice in the analytical area.
- Review and approval of laboratory related documents such as validation/transfer/ investigation protocols and reports, procedures and work instructions.
- Handle quality issues, CAPAs, and change controls that are initiated by our business partners and/or their contractors and contract laboratories.
- Ensure that Quality and Compliance operational targets are met.
- Support quality oversight via periodic quality reviews e.g. internal audits, quality metrics, round tours.
- Report Quality trends and makes a positive contribution via ideas for improvement.
- Involvement in implementation of new insights, process improvements and departmental strategic discussions.
- Support and act as spokesperson during Health Authority inspections and customer audits.
Requirements
- Master’s degree or equivalent by experience in science e.g. (bio-)pharmaceutical, chemical or biological sciences
- 3-5 years’ experience in pharmaceutical industry, preferably in Quality Assurance / Quality Control
- Operational experience and affinity with laboratory environment e.g. method development, method validation, release & stability testing, microbiology
- Operational experience in a quality role
- Technical experience in instrument qualification, automation is an asset.
- Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering in a global environment.
- Knowledge of cGMP and ICH guidelines
- Experience with regulatory inspections as spokesperson, backroom role, preparation is an asset.
- Excellent verbal and written communication skills (Dutch & English)
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancequality controlmethod developmentmethod validationrelease testingstability testingmicrobiologyinstrument qualificationautomationrisk management
Soft Skills
influencingnegotiationpartneringcommunication
Certifications
Master’s degree in science