The Quality Assurance Specialist III ensures compliance in quality operations for biologic drug substances and products, conducts quality inspections, reviews documentation, supports continuous improvement, and acts as a compliance resource for deviations and investigations. The role involves collaboration with various departments and supports regulatory inspection preparations.

The Sr. Analyst, Quality Control Analytical will oversee testing for commercial and clinical drug products, author and revise relevant SOPs and documentation, lead investigations, and participate in process optimization within a GMP environment. Responsibilities include performing analytical assays and supporting method development to ensure quality compliance.

The Lead Analyst in Quality Control Analytical oversees testing of drug products and substances, leads investigations and method optimizations, reviews lab documentation, authors quality records, and supports method development and validation activities while ensuring compliance with cGMP regulations.