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Quality Assurance Engineer II
2 months ago
Are you dedicated to ensuring quality standards in the biotechnology sector? Join Compunnel Inc. as a Quality Assurance Engineer II and contribute significantly to our commitment to excellence.
Position: Quality Assurance Engineer II
Location: On-site
Contract Duration: 12 months (with potential for extension)
Role Overview: In the capacity of Quality Assurance Engineer II, you will be instrumental in the development and enhancement of our Quality Management System (QMS) and Regulatory Affairs (RA) initiatives. Your role will involve ensuring adherence to current Good Manufacturing Practices (cGMPs), 21 CFR 820, ISO 13485, and established Quality System Procedures while overseeing new product introductions and quality improvement projects for serum products.
Key Responsibilities:
- Design and sustain QMS/RA initiatives to meet quality objectives and performance metrics.
- Oversee the introduction of new products and associated projects.
- Guarantee compliance with evolving regulations, including Quality System Regulations (QSRs) and international import/export laws.
- Collaborate with regulatory bodies on compliance matters.
- Implement and manage Corrective and Preventive Actions (CAPA) and problem-solving processes.
- Coordinate quality documentation, manage nonconformance reports, and oversee product disposition.
- Conduct internal audits and support customer and supplier audit processes.
- Act as a resource for customer regulatory and technical inquiries.
Qualifications:
- Bachelor's degree in a relevant field such as Science, Engineering, or Bioengineering (Chemistry or Biology preferred).
- A minimum of 3 years of experience in Quality or Regulatory roles, ideally within the medical device, pharmaceutical, or biotechnology sectors.
- Comprehensive understanding of Quality Systems Regulations 21 CFR 820 and ISO 13485.
- Experience with internal and external audits, CAPA, and continuous improvement practices.
- Strong analytical and problem-solving capabilities.
Preferred Skills:
- Familiarity with SAP, EtQ, and/or PeopleSoft.
- Experience in project management.
- Knowledge of regulations regarding animal by-products in import/export.
- Understanding of animal health, virology, immunology, or epidemiology.
We provide a vibrant work environment that fosters professional development. If you possess a keen attention to detail, excellent communication abilities, and thrive in a team-oriented atmosphere, we encourage you to consider this opportunity.
