Quality Assurance Specialist — Life Sciences Compliance

Gator Bio; Palo Alto (CA); Presencial; USD 70 000 - 95 000; Tempo integral

Resumo da oferta

Gator Bio is seeking a QA Specialist to join our Quality Assurance team in Palo Alto. You will maintain the established QMS, ensure compliance with quality requirements, and support continuous improvement of quality system processes.

You will manage controlled documents, training programs, calibration and maintenance of equipment, and product/batch release. You’ll collaborate across Manufacturing, R&D, QC and Operations to resolve quality issues and support audits and CAPAs.

Qualificações

• Bachelor’s degree in life sciences or engineering is required.
• 2+ years of QA experience in a regulated environment.
• Working knowledge of Quality Management Systems and quality standards.
• Experience with quality documentation and records.
• Excellent written and verbal communication and cross‑functional collaboration.
• Ability to manage multiple priorities and follow through.

Responsabilidades

• Maintain the established QMS in accordance with standards and procedures.
• Promote awareness and compliance with quality requirements across the organization.
• Manage controlled documents, quality records, forms, and related documentation.
• Oversee document and change control activities and periodic reviews.
• Coordinate quality training programs and track completion.
• Manage equipment calibration and maintenance programs and records.
• Perform product and/or batch release with Manufacturing and QC.
• Support NCR, CAPA, complaint handling and audits as needed.
• Collaborate with Manufacturing, R&D, QC, and Operations to resolve quality issues.

Conhecimentos

Attention to detail

Organizational skills

Written and verbal communication

Cross-functional teamwork

Ability to manage multiple priorities

Formação académica

Bachelor’s degree in Life Sciences, Biology, Chemistry, Biochemistry, Engineering, or related field

Descrição da oferta de emprego

Gator Bio is seeking a QA Specialist to join our Quality Assurance team in Palo Alto. You will maintain the established QMS, ensure compliance with quality requirements, and support continuous improvement of quality system processes.

You will manage controlled documents, training programs, calibration and maintenance of equipment, and product/batch release. You’ll collaborate across Manufacturing, R&D, QC and Operations to resolve quality issues and support audits and CAPAs.