Quality Specialist

Vastek • San Diego, CA

313d • $77,189

About The Position

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. The role also includes collaboration with procurement and R&D to qualify new suppliers and improve the supply chain's overall quality, participation in biotech software quality assurance activities, reviewing and approving restrictions, configurations, and validation supporting documents, creating quality system documentation, and collecting and compiling key quality metric data. The position requires working in various unanticipated locations throughout the U.S.

Requirements

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

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.

What This Job Offers

• Job Type: Full-time
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree