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Quality Assurance Engineer II
2 months ago
Position Title: Quality Assurance Engineer II
Contract Duration: 6 months, with potential for extension
Role Summary:
As a Quality Assurance Engineer II, you will play a pivotal role in supporting the plant's Exception Report/CAPA System. Your responsibilities will include conducting thorough root cause analyses for any exceptions, nonconformities, or deviations from established procedures and specifications related to product manufacturing and packaging.
Key responsibilities include:
- Delivering comprehensive and timely exception documentation while ensuring adherence to CAPA requirements.
- Managing the exception documentation process and generating necessary exception reports.
- Leading complex investigations that have significant impacts on quality assurance.
- Ensuring all investigations comply with corporate and site-specific standards.
- Meeting all regulatory requirements associated with the Quality System's implementation and maintenance.
- Achieving Quality CAPA goals and metrics consistently.
- Fostering a culture of continuous improvement by identifying issues, performing root cause analyses, and ensuring effective implementation of corrective and preventive measures.
- Maintaining strong collaborative relationships with various Quality departments and other teams within the organization.
Qualifications:
To be successful in this role, candidates should possess:
- A Bachelor's degree in a relevant field such as Biology, Chemistry, or Engineering.
- 4-6 years of experience within the pharmaceutical sector, specifically in Manufacturing, Quality, or Engineering roles.
- Strong problem-solving capabilities and analytical skills.
- Familiarity with Quality/Compliance management, regulations, and industry standards.
Work Arrangement:
During the training phase, the position will require 100% onsite presence. Post-training, a hybrid work schedule will be implemented, allowing for 3 days onsite and 2 days remote, with some weeks necessitating full onsite attendance.
