Senior QA Investigator – GMP, Onsite Contract (Vista)

WaveCrest Staffing Group; Vista (CA); Sur place; USD 51 000 - 73 000; Plein temps

Résumé du poste

WaveCrest Staffing Group is seeking an experienced Quality Assurance Specialist II to support GMP quality operations at a pharmaceutical/biotechnology manufacturing facility in Vista, CA.

The role focuses on investigations, CAPAs, OOS, and regulatory compliance to ensure drug substances meet FDA and international quality standards; requires 5+ years in GMP pharma/biotech, RCA, CAPA management, and internal audits. This onsite contract runs through June 2027.

Qualifications

• Minimum 5 years of QA experience in GMP-regulated pharma/biotech manufacturing.
• Experience managing deviations, CAPAs, and OOS investigations.
• Strong RCA, audit support, and regulatory compliance knowledge.

Responsabilités

• Serve as QA reviewer and approver for deviations, CAPAs, OOS investigations, and nonconforming materials.
• Lead complex quality investigations with root cause analysis and corrective actions.
• Manage cross-functional investigation teams (Manufacturing, QC, Engineering, etc.).
• Review, author, and approve investigation reports ensuring audit-ready documentation.
• Develop and monitor CAPA plans to address quality issues and mitigate risks.
• Support internal and customer/regulatory audits and inspections.

Connaissances

Quality Assurance

GMP Compliance

Root Cause Analysis

Investigations

CAPA Management

Internal Audits

Regulatory Audits

Cross-functional Collaboration

Outils

Veeva Systems

MasterControl

Description du poste

WaveCrest Staffing Group is seeking an experienced Quality Assurance Specialist II to support GMP quality operations at a pharmaceutical/biotechnology manufacturing facility in Vista, CA.

The role focuses on investigations, CAPAs, OOS, and regulatory compliance to ensure drug substances meet FDA and international quality standards; requires 5+ years in GMP pharma/biotech, RCA, CAPA management, and internal audits. This onsite contract runs through June 2027.