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Job Description
Seeking experienced QA professional to lead QA operations in biotech manufacturing site, with 3+ years QA experience and 5+ years industry experience.
Our client is an expanding biotech site, transitioning from development to full-scale production. As a QA Operations Specialist, you will play a key role in ensuring the manufacture of product in accordance with GMP and regulatory requirements.
Key responsibilities:
- Manage Quality Management System (QMS) areas, including Deviation Investigations, Change Control, and CAPA management systems.
- Review and approve Manufacturing Batch Records, production materials, and Quality Control testing.
- Provide technical expertise and guidance on QA and compliance topics, including manufacturing, validations, and new product introduction.
- Act as QA lead in cross-functional teams, ensuring the application of Quality Risk Management principles.
- Contribute to continuous improvement activities and generate, review, and approve SOPs and other documentation.
As a member of the senior leadership team, you will have the opportunity to gain exposure to pre-production operations, receive full training and ongoing development, and work on a variety of interesting projects.
Key skills and qualifications:
- 3+ years QA experience and 5+ years industry experience.
- Knowledge of batch-related documentation and activities.
- Experience with GMP and regulatory requirements.
- Strong technical expertise and problem-solving skills.