Supplier Quality Specialist
Posted on: June 16, 2021
Industry: QA Testers
Job Number: JN -062021-65725
Purpose and scope of position:
- The Senior Specialist QA (CMO) position is an individual contributor role responsible for supporting Supplier Qualification activities and QA oversight of CMO viral vector manufacturing operations in accordance with business agreements and international regulatory and industry standards.
Required competencies: knowledge, skills, and abilities:
- Education: Bachelor’s degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas.
- 8+ years related industry experience with a minimum of 3 years’ experience in quality assurance, quality control, and compliance.
- Knowledge of applicable FDA/EMA regulations in the biotechnology industry.
- Strong organizational skills, including ability to follow assignments through to completion.
- Experience supporting contractor negotiations.
- With moderate oversight from manager, think strategically and understand global impact of decisions.
- Excellent verbal and written communication skills.
- Detail-oriented with demonstrated applications in problem solving.
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