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
quality assurancequality controlmethod developmentmethod validationrelease testingstability testingmicrobiologyinstrument qualificationautomationrisk management
Soft skills
influencingnegotiationpartneringcommunication
Certifications
Master’s degree in science