Quality Assurance Consultant, Biopharmaceutical Manufacturing

Job overview

The Quality Assurance Consultant, Biopharmaceutical Manufacturing role is onsite in San Jose, CA. Compensation is not specified. The consultant supports manufacturing compliance and remediation ahead of an anticipated FDA inspection in early 2027, as the company advances toward a Biologics License Application. The role addresses deviations, CAPAs, and quality findings to strengthen manufacturing compliance and inspection readiness. It works with Quality Assurance, Manufacturing, and other cross-functional teams to investigate issues, review records, and document corrective actions.

What you'll do

• Review and address manufacturing deviations and CAPAs identified through internal audits
• support root-cause investigations and corrective and preventive action plans
• evaluate manufacturing processes and documentation for compliance gaps
• review GMP batch production records
• support corrective-action development, execution, and documentation
• partner with Quality Assurance, Manufacturing, and other teams to resolve quality issues
• maintain inspection-ready records
• support inspection readiness and quality activities related to the BLA submission.

What we're looking for

Skills & competencies

quality assurance consultant

biopharmaceutical manufacturing

san jose ca

onsite

gmp

capa

deviation investigations

batch records

fda inspection readiness

bla support

quality compliance

katalyst healthcares & life sciences

Work arrangement

• Weekend coverage required

Why this role

Three-month engagement focused on GMP manufacturing remediation and preparation for an anticipated FDA inspection between February and April 2027.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.