Quality Assurance Specialist

Description

Provide quality oversight for manufacturing operations, ensuring compliance with cGMP regulations and internal procedures. Review and disposition raw materials, plasmids, drug substance, and drug product batches. Review and approve batch production records, testing records, and manufacturing documentation. Support batch record review and release activities for materials and products. Review, investigate, and document deviations, ensuring appropriate corrective and preventive actions are implemented. Author, review, and revise SOPs, batch records, policies, and training materials. Participate in real-time quality oversight activities within manufacturing operations and cleanroom environments. Partner with cross-functional teams to support manufacturing readiness, startup activities, and continuous improvement initiatives. Ensure adherence to data integrity principles and training requirements. Monitor manufacturing operations for compliance with established specifica...