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Gator Bio
Palo Alto, CA
Source: Gator Bio careers · View original posting
From Gator Bio's posting. “We” and “our” refer to the employer.
Gator Bio is a bioanalytical technology company located in Palo Alto, CA. We are creating innovative technologies to solve difficult problems facing today’s biopharma industry. We develop, manufacture, and sell instruments, biosensors, reagents, and consumables for antibody, gene, and cell therapy development. Gator Bio’s current product portfolio includes biolayer interferometry (BLI) systems using optic fiber biosensors.
We are looking for a QA Specialist to join our Quality Assurance team. The QA Specialist will play an important role in maintaining the company’s established Quality Management System (QMS), ensuring compliance with applicable quality requirements, and supporting the continuous improvement of quality system processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Quality Management System
Maintain the established Quality Management System (QMS) in accordance with applicable standards and company procedures.
Promote awareness and compliance with quality requirements across the organization.
Document and Change Control
Manage controlled documents, quality records, forms, and other quality-related documentation.
Manage document and change control activities, including document revisions, approvals, implementation, and periodic reviews.
Training
Manage the quality training program, including the training matrix, training assignments, and completion tracking.
Follow up on overdue training and maintain training records.
Coordinate training related to quality system procedures and requirements.
Equipment Calibration and Maintenance
Manage the equipment calibration and maintenance program.
Monitor calibration and maintenance schedules and due dates.
Maintain calibration and maintenance records and follow up to ensure activities are completed on time.
Support the evaluation and documentation of out-of-calibration or out-of-service equipment.
Product Release
Perform product and/or batch release by reviewing required quality records and documentation.
Work with Manufacturing and QC to ensure quality requirements are completed prior to release.
Support the investigation and resolution of quality issues that may affect product quality or release.
Quality Activities Support
Support nonconformance (NCR), CAPA, complaint handling, and audit activities as needed.
Perform other QA and quality-related activities as assigned.
Maintain appropriate records and documentation for assigned quality activities.
Cross-Functional Support
Work closely with Manufacturing, R&D, QC, Operations, and other functions to support quality activities and resolve quality issues.
Provide timely QA support for projects and operational activities.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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