Position Overview :
Our client in San Jose, CA, is seeking a Quality Assurance Consultant for a three-month engagement to support manufacturing compliance initiatives and remediation activities in preparation for an anticipated FDA inspection in early 2027.
The consultant will focus on addressing manufacturing deviations, CAPAs, and quality findings identified through internal facility and manufacturing line audits. Responsibilities may also include reviewing GMP batch records, evaluating documentation for compliance, and supporting efforts to ensure manufacturing operations are inspection-ready as the company advances toward a Biologics License Application (BLA).

The ideal candidate brings experience in pharmaceutical or biopharmaceutical manufacturing quality, deviation investigations, CAPA management.
Roles and Responsibilities:

• Review and address manufacturing deviations and CAPAs identified through internal audits of the facility and manufacturing operations.
• Support root cause investigations, develop corrective and preventive action plans, and assist with timely resolution of outstanding quality issues.
• Evaluate manufacturing processes and documentation to identify compliance gaps and opportunities for remediation.
• Review GMP batch production records for completeness, accuracy, adherence to procedures, and compliance with applicable quality requirements.
• Support the development, execution, and documentation of corrective actions to strengthen compliance.
• Partner with Quality Assurance, Manufacturing, and other cross-functional teams to resolve quality issues and ensure effective implementation of remediation activities.
• Maintain accurate, complete, and inspection-ready documentation of investigations, CAPAs, and related quality activities.
• Support inspection-readiness initiatives in anticipation of an FDA inspection expected between February and April 2027.
• Contribute to quality and compliance activities supporting the company's progress toward a BLA submission.

Required Qualifications:

• Experience in Quality Assurance, Quality Compliance, or Manufacturing Quality within the pharmaceutical or biopharmaceutical industry.
• Hands-on experience investigating manufacturing deviations and managing CAPAs in a GMP-regulated environment.
• Experience reviewing batch records and manufacturing documentation.
• Strong investigation, documentation, organizational, and problem-solving skills.
• bility to work independently, prioritize remediation activities, and deliver results within a defined contract period.