Quality System Scientific Specialist Tier III

Job description

Description Job Purpose: The purpose of the Quality Systems Scientific Specialist (Tier III) is to responsible for ensuring data integrity, compliance, and adherence to established quality standards. This role involves analyzing reports, and identifying discrepancies or inconsistencies, and escalating issues accordingly. Contribute to continuous improvement of processes and products by identifying trends all while adhering to regulatory standards and company policies. Essential Duties and Responsibilities: - Responsible for ensuring compliance with all State and Federal regulatory bodies as it pertains to the completion of Annual Product Reviews (APR) for all Nephron Pharmaceuticals Corporation (Nephron) and Nephron 503B Outsourcing Facility (503B) drug products. - Responsible for performing Quality Assurance reviews of Microbiology and Chemistry documents for final Quality Approval. This includes review of method validation protocols and summary reports, Media Fills, environmental monitoring performances qualifications, drug supply chain security act, and other related documentation provided to the Quality Systems Scientific Team. - Review and approval of protocols and summary rep...