Quality Assurance Specialist
Gator Bio· Operations – Quality Assurance
Palo Alto, CA$70k - $95kRegular, Full-TimePosted 1w ago
About the role
QA Specialist to maintain and improve the Quality Management System (QMS) and support quality processes across the organization in a life sciences manufacturing environment.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Qualifications
- Bachelor’s degree in Life Sciences, Biology, Chemistry, Biochemistry, Engineering, or a related scientific or technical field.
- 2+ years of experience in Quality Assurance in a life science, biotechnology, diagnostics, medical device, or other regulated environment.
- Working knowledge of Quality Management Systems and applicable quality standards.
- Experience with quality documentation and records.
- Attention to detail and organizational skills.
- Ability to manage multiple priorities and follow through on assigned activities.
- Written and verbal communication skills.
- Ability to work effectively with cross-functional teams.
Skills
Required:Quality Management System (QMS)Document ControlTraining Management
Nice to have:Equipment Calibration and MaintenanceProduct/Batch ReleaseQuality Issues InvestigationGxP / ISO 13485 / FDA-regulated Knowledge
Last updated Oct 21, 2026. Interested? Apply on the company site.
About Gator Bio
Accelerate discovery with Next-Gen Biolayer Interferometry
Explore the Biomolecular universe using our BLI Technology (Biolayer Interferometry) to bring greater meaning to every molecule.
Biolayer InterferometryBLI Technologybiomolecular interactionshigh-throughput analysisresearch tools
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