Quality Assurance Specialist

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.

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.

QUALIFICATIONS

Required

• 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.

Preferred

• 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. 

PHYSICAL REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• This role will require lengthy periods of standing and sitting.
• The employee will be required to use hands for computer work.
• Health screening: Not required
Travel: N/A