QA Consultant for FDA Readiness & CAPA (3-Month)

Katalyst-Healthcares-; San Jose (CA); On-site; USD 148,000 - 221,000; Full time

Job summary

Katalyst-Healthcares- is seeking a Quality Assurance Consultant in San Jose, CA for a 3-month engagement to support manufacturing compliance and remediation ahead of an FDA inspection planned for early 2027.

The ideal candidate will have pharmaceutical/biopharmaceutical QA experience, with hands-on deviation investigations, CAPA management, and batch records review to ensure inspection readiness.

Qualifications

• Experience in Quality Assurance within pharmaceutical/biopharmaceutical industry.
• Hands-on experience investigating manufacturing deviations and managing CAPAs in a GMP environment.
• Experience reviewing batch records and manufacturing documentation.
• Strong investigation, documentation, organizational, and problem-solving skills.
• Ability to work independently and deliver results within contract period.

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 quality issues.
• Evaluate manufacturing processes and documentation to identify compliance gaps and remediation opportunities.
• Review GMP batch production records for completeness, accuracy, and adherence to procedures.
• Support development, execution, and documentation of corrective actions to strengthen compliance.
• Collaborate with QA, Manufacturing, and cross-functional teams to resolve quality issues and implement remediation activities.
• Maintain accurate, inspection-ready documentation of investigations, CAPAs, and related quality activities.
• Support inspection-readiness initiatives ahead of FDA inspection (Feb-Apr 2027).
• Contribute to quality and compliance activities toward a BLA submission.

Skills

Quality assurance

CAPA management

GMP experience

Investigation

Job description

Katalyst-Healthcares- is seeking a Quality Assurance Consultant in San Jose, CA for a 3-month engagement to support manufacturing compliance and remediation ahead of an FDA inspection planned for early 2027.

The ideal candidate will have pharmaceutical/biopharmaceutical QA experience, with hands-on deviation investigations, CAPA management, and batch records review to ensure inspection readiness.