QA Associate II - GMP Compliance & Documentation

Aspen Neuroscience, Inc.; San Diego (CA); Presencial; USD 76.000 - 92.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical/Dental insurance

Onsite gym

Paid time off

Descripción de la vacante

Aspen Neuroscience, Inc. in San Diego, CA, seeks a Quality Assurance Associate II to support cGMP manufacturing activities in an on-site role.

You will review documentation, support deviation closures, and participate in audits, ensuring compliant materials, processes, and products. The ideal candidate holds a BA/BS in biological sciences with at least 2 years GMP manufacturing experience, strong documentation review skills, and the ability to work with cross-functional teams in a fast-paced

Formación

• Bachelor’s degree in biological sciences or relevant field; minimum 2 years GMP manufacturing experience.
• Experience in regulated environments (GMP/GLP); cell therapies a plus.
• Experience in aseptic technique, drug safety testing, and environmental monitoring a plus.
• Experience in controlled clean rooms (ISO 5/ISO7) is a plus.

Responsabilidades

• Review batch records, analytical results, environmental monitoring data, deviations, CAPAs, and change controls.
• Close deviations, discrepancies, and nonconformance records per procedures.
• Independently review GMP documentation and correct errors.
• Conduct QA line clearance inspections and process observations for compliance.
• Support release of raw materials, equipment and supplier qualification activities.
• Participate in audits by providing documentation and quality support.
• Contribute to investigations and CAPA implementation.
• Assist in maintaining quality systems and process improvements.
• Draft and revise SOPs and manufacturing documentation.

Conocimientos

Quality systems knowledge

Documentation review

Problem solving

Attention to detail

Collaboration

Communication

Adaptability

MS Office & QMS

Cleanroom operations

Schedule flexibility

Educación

Bachelor’s degree in Biological Sciences

Herramientas

Microsoft Office

Electronic QMS

Descripción del empleo

Aspen Neuroscience, Inc. in San Diego, CA, seeks a Quality Assurance Associate II to support cGMP manufacturing activities in an on-site role.

You will review documentation, support deviation closures, and participate in audits, ensuring compliant materials, processes, and products. The ideal candidate holds a BA/BS in biological sciences with at least 2 years GMP manufacturing experience, strong documentation review skills, and the ability to work with cross-functional teams in a fast-paced