Quality Assurance Specialist II *PC 821

Job description

Your Role: This position supports daily Quality Assurance activities at the Auburn site, including material release, documentation and archival management. The role ensures compliance with GMP, GDP, and company procedures while contributing to site inspection readiness and long-term QA system development. Requirements: Skills: - Provide on-site QA support by monitoring daily operations for compliance and promptly reporting any quality concerns or high-risk issues to management. - Assist with maintaining QA systems such as Deviation, CAPA, Change Control, Supplier Qualification, and Document Control. Support SOP revisions, ensure procedures are followed, and participate in staff training as directed. - Prepare and review documentation for accuracy, completeness, and compliance with GMP, GDP, and ISO standards. Escalate issues or inconsistencies to QA management for further evaluation. - Support internal and external audits by organizing evidence, coordinating assigned responses, and tracking timely completion of follow-up actions within QA systems to maintain inspection readiness. - Perform on-floor GDP checks and self-inspections to verify compliance and identify improvement opport...