Quality Specialist Jobs

This position is primarily responsible for providing Quality Assurance support for manufacturing operations to ensure compliance with cGMP, internal procedures, and regulatory requirements. This role performs on-the-floor QA oversight, batch record review, product disposition activities, and supports the investigation and review of deviations and other quality events. The role involves 2nd shift OTF support or weekends, providing QA on-the-floor support to manufacturing, packaging, and warehouse operations to ensure compliance with cGMP and site procedures. It includes performing real-time line checks, AQL inspections, and verification of critical steps in production processes. The specialist will review executed batch records, logbooks, and other production documentation for completeness, accuracy, and compliance prior to disposition. They will also assist in product disposition by preparing QA summaries, verifying data integrity, and ensuring all release criteria are met. The role supports the initiation and review of Change Controls and deviations, ensuring thorough root cause analysis and appropriate corrective and preventive actions (CAPA). Collaboration with manufacturing, quality control, and MSAT teams to resolve issues identified during production or review is essential. The specialist will participate in quality investigations and continuous improvement initiatives, ensuring adherence to all safety and environmental requirements and maintaining current knowledge of applicable cGMP regulations and company quality policies. Additionally, the role involves performing final review of room, equipment, and facility records and associated support systems to release areas for cGMP operations, reviewing documentation to determine release status, and approving material for release or nonconformance investigation. Assisting in internal compliance and external (supplier) audits as assigned is also part of the responsibilities. The position requires the ability to support 24/7 process operations and shift schedules.