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The Quality Assurance Specialist is responsible for inspecting incoming materials for GMP production, assisting with packaging floor activities, reviewing production batch records, ensuring compliance with FDA guidelines, and participating in Quality programs to guarantee product standards. The role involves data gathering, managing investigations, and interacting with clients while following Good Documentation Practices and relevant guidelines.

The Quality Assurance Specialist II - Quarantine is responsible for auditing products and processes in production and packaging to ensure adherence to quality standards. Duties include sampling materials, reporting deviations, overseeing the quarantine release process, generating controlled documents, and ensuring compliance with FDA and cGMP standards.

The Continuous Improvement Principal will drive sustainable improvements in manufacturing operations by utilizing lean and 6 Sigma methodologies, creating solutions for operational problems, and collaborating with different departments. Responsibilities include planning and executing continuous improvement projects, leading Kaizen events, and mentoring team members.

The Operator I, Form/Fill role involves operating filling equipment for pre-filled syringes and vials, performing sterile filtration, running machinery, conducting quality checks, and more to ensure compliance and quality in the production process.

The Senior Scientist, QC will independently execute and document cGMP Quality Control testing, operate analytical equipment, author technical documents, and ensure data accuracy. The role involves coordinating activities, supporting continuous improvement, and training in analytical techniques.

The Specialist, QA – Batch Disposition ensures Quality Assurance for GMP documentation related to cell and gene therapy products. Responsibilities include reviewing batch records, supporting internal quality functions, ensuring compliance with industry standards, and reporting on performance metrics while contributing to process improvements.

The Senior Manager of Quality Management Systems will lead compliance and regulatory audits, implement process improvements, oversee supplier audits, ensure compliance with cGMPs and FDA regulations, and manage a compliance team while mentoring staff. Responsibilities include monitoring training programs, providing findings to management, and developing departmental procedures.