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Gator Bio

Biomolecular interaction analysis via BLI sensors

Quality Assurance Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timePalo Alto, CA, USA$70k - $95k /yr

About the Job

Requirements

  • A bachelor's degree in Life Sciences, Biology, Chemistry, Biochemistry, Engineering, or a related scientific or technical field is required.
  • At least 2 years of Quality Assurance experience in a life science, biotechnology, diagnostics, medical device, or other regulated environment is required.
  • Working knowledge of Quality Management Systems and applicable quality standards is required.
  • Experience with quality documentation and records is required.
  • Attention to detail and organizational skills are required.
  • Ability to manage multiple priorities and follow through on assigned activities is required.
  • Written and verbal communication skills are required.
  • Ability to work effectively with cross-functional teams is required.

Responsibilities

  • Maintain the established Quality Management System 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, corrective and preventive action, 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.
  • The role requires lengthy periods of standing and sitting and use of hands for computer work.

Desired Qualifications

  • Experience working in an ISO 13485, FDA-regulated, or other regulated life science environment is preferred.
  • Experience performing product or batch release is preferred.
  • Experience with equipment calibration and maintenance programs is preferred.
  • Experience with electronic QMS or other quality management systems is preferred.
  • Familiarity with GxP requirements is preferred.
  • Experience working in an IVD, biotechnology, medical device, or analytical instrument environment is preferred.

About the Company

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Gator Bio

Biomolecular interaction analysis via BLI sensors

Gator Bio provides biomolecular interaction analysis tools based on Biolayer Interferometry (BLI). It sells BLI instruments and reusable biosensors that let researchers study how molecules such as proteins and small compounds interact in real time. The BLI system detects changes in light interference on a sensor surface as molecules bind, producing data on binding, kinetics, quantitation, and epitope binning. The company differentiates itself by offering an integrated hardware-and-consumables platform plus technical support, training, and maintenance for pharma, academic labs, and biotech firms that need reliable molecular interaction data. Its goal is to help customers accelerate drug discovery and clinical research with precise, easy-to-use biomolecular analysis tools.

Company size
51-200
Company stage
Not listed
Total funding
Not listed
Headquarters
Palo Alto, CA
Founded
2017

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