Quality Systems Specialist - CAPA & Compliance (Biopharma)

Avid Bioservices; Tustin (CA); On-site; USD 90,632,000 - 120,806,000; Full time

Job summary

Avid Bioservices is seeking a Specialist, Quality Systems to support the Quality Management System, focusing on discrepancy processing and CAPA records. You will collaborate with cross-functional teams, maintain inspection readiness, and ensure regulatory compliance while delivering high-quality responses to internal and external stakeholders.

The role emphasizes data verification, deviation tracking, and ongoing improvement within a fast-paced biopharma environment onsite in California.

Qualifications

• 2–4 years of experience in Quality Assurance is required.
• Knowledge of cGMPs or equivalent regulations.
• Ability to interpret Quality standards for implementation.
• Skills to independently evaluate situations and propose potential solutions.

Responsibilities

• Update channels for tracking Quality Event deviation reports and CAPAs.
• Coordinate with cross-functional teams to meet due dates.
• Interact with interdepartmental contacts on discrepancy reports and CAPA records; represent Quality on teams.
• Perform data verification to ensure accuracy in Quality Events.

Skills

Quality Assurance

cGMPs

Data Verification

CAPA Management

Documentation

Cross-functional Collaboration

Education

Bachelor’s degree in Life Sciences

Tools

Quality Management Systems (QMS)

Electronic Document Management Systems

Job description

Avid Bioservices is seeking a Specialist, Quality Systems to support the Quality Management System, focusing on discrepancy processing and CAPA records. You will collaborate with cross-functional teams, maintain inspection readiness, and ensure regulatory compliance while delivering high-quality responses to internal and external stakeholders.

The role emphasizes data verification, deviation tracking, and ongoing improvement within a fast-paced biopharma environment onsite in California.