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Research Scientist II
2 months ago
Position Overview:
The Research Scientist II plays a crucial role in the execution of comprehensive investigation reports to support operations. This position requires a thorough understanding of root cause analysis and the ability to engage with various teams to ensure quality and compliance.
Key Responsibilities:
The successful candidate will be tasked with:
- Conducting detailed investigations and analyses to identify root causes of deviations.
- Collaborating with personnel across different departments to gather information and insights.
- Documenting findings and drafting investigation reports with clear corrective and preventive actions.
- Utilizing statistical analysis tools to support data trending and tracking.
- Preparing for and assisting with health authority inspections.
Essential Qualifications:
To be considered for this role, candidates must possess:
- A Bachelor's degree in a scientific or engineering discipline, with a preference for Biochemistry or life sciences.
- A minimum of one year of relevant experience in a regulated environment.
- Experience in biopharmaceutical manufacturing, particularly CAR-T, is advantageous.
Competencies:
The ideal candidate will demonstrate:
- Proficiency in deviation investigations and the CAPA process.
- Strong technical writing and communication skills.
- Ability to manage priorities and adapt to changing situations effectively.
- Experience with electronic Quality systems.
Work Environment:
This position is primarily office-based, with occasional requirements to work in manufacturing or laboratory settings. Flexibility in working hours is essential to meet project deadlines.
