Senior QA Investigator – GMP/Pharma (Onsite)

ASQ; Vista (CA); On-site; USD 51,000 - 73,000; Full time

Job summary

ASQ is seeking an experienced Quality Assurance Specialist II to support GMP operations at a Vista, CA pharmaceutical/biotech manufacturing site. The role focuses on quality investigations, CAPA management, deviations, and OOS investigations to ensure FDA and international quality standards are met.

You will collaborate with Manufacturing, Quality Control, Engineering and other functions, lead cross-functional investigation teams, review reports, and drive CAPA effectiveness.

Qualifications

• Minimum 5 years QA experience in GMP-regulated pharmaceutical or biotechnology manufacturing.
• Hands-on experience managing deviations, CAPAs, and OOS investigations.
• Demonstrated experience conducting root cause analysis and leading quality investigations.
• Experience supporting manufacturing operations in a GMP environment.
• Experience participating in or supporting internal quality audits.
• Strong understanding of FDA regulations and pharmaceutical quality systems.

Responsibilities

• Serve as QA reviewer and approver for deviations, CAPAs, OOS investigations, and nonconforming materials.
• Lead complex quality investigations, performing RCA to identify underlying issues and corrective actions.
• Manage cross-functional investigation teams with Manufacturing, QC, Engineering and others.
• Review, author, and approve detailed investigation reports for accuracy and audit-readiness.
• Develop, implement, and monitor CAPA plans to address quality issues and mitigate risks.
• Support internal and customer/regulatory audits to ensure GMP compliance.
• Identify compliance risks and recommend corrective actions to maintain standards.
• Provide QA oversight to manufacturing operations and ensure adherence to procedures.
• Track quality metrics, timelines, and CAPA performance for management updates.

Skills

Quality investigations

CAPA management

Root cause analysis

OOS investigations

FDA/cGMP knowledge

Cross-functional collaboration

Tools

Veeva

MasterControl

Job description

ASQ is seeking an experienced Quality Assurance Specialist II to support GMP operations at a Vista, CA pharmaceutical/biotech manufacturing site. The role focuses on quality investigations, CAPA management, deviations, and OOS investigations to ensure FDA and international quality standards are met.

You will collaborate with Manufacturing, Quality Control, Engineering and other functions, lead cross-functional investigation teams, review reports, and drive CAPA effectiveness.