Quality Assurance Specialist
2 days ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at SOFIE. As a key member of our quality management team, you will be responsible for ensuring the highest standards of quality and regulatory compliance across our network of facilities.
Key Responsibilities- Support the development and implementation of quality management systems and procedures
- Provide backup support to network facilities on quality-related matters, including exception management and CAPA/CC initiatives
- Collaborate with site quality assurance specialists to ensure compliance with regulatory requirements and company policies
- Participate in continuous improvement initiatives, including the design and presentation of training programs and the execution of CAPA/CC initiatives
- Serve as a backup for site quality assurance specialists, providing support on quality-related matters and ensuring compliance with regulatory requirements
- Bachelor's degree in a scientific or medical field, or equivalent experience
- Experience in manufacturing operations, aseptic processing, and distribution of aseptic products
- Knowledge of USP, FDA, and cGMP regulations
- Ability to write, review, and revise SOPs
- Strong interpersonal communication skills and ability to work effectively with site personnel, inspectors, and internal and external vendors
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality and regulatory compliance, we encourage you to apply for this exciting opportunity.
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Quality Assurance Specialist
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