Quality Systems Specialist - CAPA & Compliance (Biopharma)

avidbio; Tustin (CA); On-site; USD 90,632,000 - 120,860,000; Full time

Job summary

Avid Bioservices is seeking a Specialist, Quality Systems to support the Quality Management System and CAPA/Discrepancy processing. You will work with cross-functional teams to ensure compliance, inspection readiness, and timely resolution of quality events.

This onsite role requires strong data verification, document control, and collaboration with leadership to meet targets while following regulatory requirements.

Qualifications

• Bachelor’s degree in Life Sciences or equivalent industry experience.
• 2–4 years of Quality Assurance experience.
• Knowledge of cGMPs.
• Ability to interpret Quality standards for implementation.
• Strong problem-solving and independent evaluation.

Responsibilities

• Update channels for tracking Quality Event deviations and CAPAs.
• Coordinate with cross-functional teams to meet due dates.
• Interact with contacts on discrepancy reports and controlled documents.
• Verify data accuracy in Quality Events.
• Gather documentation for investigation of Quality Events.
• Monitor CAPAs for due dates and effectiveness checks.
• Pull information from Veeva QMS to meet targets.
• Collaborate with leadership to set targets and timelines.
• Follow company policies and procedures.

Skills

Quality Assurance

cGMP knowledge

Data interpretation

Independent thinking

Education

Bachelor’s degree in Life Sciences

Tools

Veeva QMS

Job description

Avid Bioservices is seeking a Specialist, Quality Systems to support the Quality Management System and CAPA/Discrepancy processing. You will work with cross-functional teams to ensure compliance, inspection readiness, and timely resolution of quality events.

This onsite role requires strong data verification, document control, and collaboration with leadership to meet targets while following regulatory requirements.