Quality Systems Specialist: CAPA & Compliance

Avid Bioservices, Inc.; Tustin, Northern (CA, KY); Hybrid; USD 44,000 - 58,000; Full time

Job summary

Avid Bioservices, Inc. in California (Tustin) seeks a Specialist, Quality Systems to support the Quality Management System. You will process discrepancy reports and CAPA records, ensuring regulatory compliance and inspection readiness, while collaborating across teams to maintain timelines.

The role requires a Life Sciences degree or equivalent experience, 2–4 years in QA, and familiarity with cGMPs and QMS tools. Onsite, regular hours, with potential overtime as needed.

Qualifications

• Bachelor’s degree (or equivalent industry experience).
• 2-4 years of experience in Quality Assurance.
• Knowledge of cGMPs or equivalent regulations.
• Ability to interpret Quality standards for implementation.
• Independent evaluation and problem-solving skills.

Responsibilities

• Update channels for tracking Quality Event deviation reports and CAPAs.
• Collaborate with cross-functional teams to meet due dates.
• Interact on discrepancy reports, CAPA records, and controlled documents; represent Quality on teams.
• Perform data verification to ensure accuracy of Quality Events.
• Gather documentation for investigation of Quality Events.
• Monitor CAPAs for due dates and effectiveness checks.
• Update trackers and pull information from Veeva QMS.
• Collaborate with Lead Specialist and Management to meet targets.

Skills

Quality Assurance

Data verification

Documentation

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor’s degree in Life Sciences

Tools

Veeva QMS

Job description

Avid Bioservices, Inc. in California (Tustin) seeks a Specialist, Quality Systems to support the Quality Management System. You will process discrepancy reports and CAPA records, ensuring regulatory compliance and inspection readiness, while collaborating across teams to maintain timelines.

The role requires a Life Sciences degree or equivalent experience, 2–4 years in QA, and familiarity with cGMPs and QMS tools. Onsite, regular hours, with potential overtime as needed.