Quality Assurance Specialist
About The Position
Gator Bio is a bioanalytical technology company located in Palo Alto, CA, focused on creating innovative technologies for the biopharma industry. They develop, manufacture, and sell instruments, biosensors, reagents, and consumables for antibody, gene, and cell therapy development, utilizing biolayer interferometry (BLI) systems with optic fiber biosensors. The company is seeking a QA Specialist to join their Quality Assurance team. This role is crucial for maintaining the company’s established Quality Management System (QMS), ensuring compliance with quality requirements, and contributing to the continuous improvement of quality system processes.
Requirements
- 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.
Nice To Haves
- Experience working in an ISO 13485, FDA-regulated, or other regulated life science environment.
- Experience performing product or batch release.
- Experience with equipment calibration and maintenance programs.
- Experience with electronic QMS or other quality management systems.
- Familiarity with GxP requirements.
- Experience working in an IVD, biotechnology, medical device, or analytical instrument 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
