Quality Specialist

Position Overview

VAStek Inc. has openings in San Diego, CA for a Quality Specialist. The role involves conducting validation studies for biotechnology manufacturing processes to ensure compliance with regulatory standards such as GMP and FDA guidelines. The Quality Specialist will evaluate critical control points and verify adherence to SOPs, oversee quality testing of biotechnology products such as biologics and vaccines by performing assays including ELISA, PCR, and HPLC, and ensure all batches meet established quality criteria before product release. Additionally, the specialist will conduct supplier audits and evaluations to ensure raw materials and components used in biotechnology production meet predefined quality specifications, collaborate with procurement and R&D to qualify new suppliers and improve supply chain quality, participate in biotech software quality assurance activities, review and approve restrictions, configurations, and validation supporting documents, create quality system documentation, and collect and compile key quality metric data. The position requires working in various unanticipated locations throughout the U.S.

Key Responsibilities

• Conduct validation studies for biotechnology manufacturing processes to ensure compliance with regulatory standards such as GMP and FDA guidelines.
• Evaluate critical control points and verify adherence to SOPs.
• Oversee quality testing of biotechnology products such as biologics and vaccines by performing assays including ELISA, PCR, and HPLC.
• Ensure all batches meet established quality criteria before product release.
• Conduct supplier audits and evaluations to ensure raw materials and components meet predefined quality specifications.
• Collaborate with procurement and R&D to qualify new suppliers and improve supply chain quality.
• Participate in biotech software quality assurance activities.
• Review and approve restrictions, configurations, and validation supporting documents.
• Create quality system documentation.
• Collect and compile key quality metric data.

Required Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry, or related field.