Quality Assurance Specialist I (Swing Shift) *PC 1512

Job description

Your Role: This position is primarily responsible for the maintenance of quality operations and processes to assure GMP compliance for relevant operations carried out, including activities related to preclinical and clinical supplies and potentially commercial production. Requirements: - Implement and maintain quality documentation, including equipment master files, personnel training files, controlled material files, and document control files. - Update specifications per current USP and EP editions. - Perform quality reviews for maintenance work orders and instrument calibration assessments. Review equipment cycle and monitoring data to ensure proper operation. - Perform final review of room, equipment, and facility records and associated support systems to release areas for cGMP operations. - Perform review of documentation to determine release status. Approve material for release or nonconformance investigation. - Approve the mechanism for isolating and/or quarantining equipment, facilities, or materials that fail to meet required specifications. - Quarantine Product pending final release testing. - Conduct review of batch production records and supporting batch documentation,...