QA Auditor: Regulatory Compliance & Audit Expert

avidbio; Tustin (CA); Hybrid; USD 103,200 - 129,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices is seeking an experienced Quality Assurance professional to join our team as an Internal/External Audit Specialist. You will ensure compliance with cGMP and regulatory requirements by conducting audits, reviewing data and docs, and preparing audit reports.

You will support corrective actions, supplier quality, and continuous improvement of QA processes. This role emphasizes regulatory compliance, adherence to our quality policy, and SOP development.

Qualifications

• BA/BS in Life Science and 5+ years in pharma/biopharma
• Solid knowledge of cGMPs or equivalent regulations
• Ability to interpret and apply quality standards
• Ability to prioritize and manage resources
• Audit skills and/or certification preferred

Responsibilities

• Perform internal and external audits for adherence to cGMPs and regulations
• Follow up on audit responses and corrective actions
• Review vendor data, records and documents for materials in a cGMP environment
• Process new vendor requests and perform qualification activities
• Serve as QA compliance representative on cross‑functional teams
• Identify and implement process and system improvements
• Evaluate regulatory changes and impacts on operations
• Support client audits and regulatory inspections (FDA/foreign)

Skills

Auditing

cGMP

Quality systems

Regulatory compliance

SOP writing

Documentation review

Education

BA/BS in Life Science

Job description

Avid Bioservices is seeking an experienced Quality Assurance professional to join our team as an Internal/External Audit Specialist. You will ensure compliance with cGMP and regulatory requirements by conducting audits, reviewing data and docs, and preparing audit reports.

You will support corrective actions, supplier quality, and continuous improvement of QA processes. This role emphasizes regulatory compliance, adherence to our quality policy, and SOP development.