Senior QC Analytics Lead — Method Transfer & Investigations

GeneFab; Alameda (CA); On-site; USD 62,000 - 76,000; Full time

Job summary

GeneFab is seeking an experienced QC Analyst to join its Quality Control Analytical group in support of GMP QC testing, method transfer, qualification, troubleshooting, and investigations. You will lead investigations, develop SOPs, and collaborate across MSAT, ASAT, and Manufacturing to ensure cGMP compliance.

The role requires at least 5+ years of GMP/QC laboratory experience and a BS in biology or a related field. Availability for extended hours may be needed to meet deadlines.

Qualifications

• B.S. degree in biology or related field with GMP/QC experience.
• Proven ability to collaborate across teams.
• Strong organizational skills and attention to detail.
• Experience with analytical methods and QC testing.

Responsibilities

• Provide SME technical support to Analytical Development and QC Analytical Operations.
• Develop, update, and maintain QC SOPs, testing records, and cGMP documentation.
• Perform QC testing on in-process and final product samples for release and stability.
• Lead and perform root-cause investigations for deviations in analytical methods.
• Plan and execute method transfers, qualifications, and validations.
• Draft and review Method Transfer Protocols and reports.
• Collaborate with MSAT, ASAT, and Manufacturing for method optimization and troubleshooting.

Skills

GMP/QC expertise

Cross-functional collaboration

Analytical troubleshooting

Time management

Education

BS in Biology or related field

Tools

LIMS

ELN

MS Office

Job description

GeneFab is seeking an experienced QC Analyst to join its Quality Control Analytical group in support of GMP QC testing, method transfer, qualification, troubleshooting, and investigations. You will lead investigations, develop SOPs, and collaborate across MSAT, ASAT, and Manufacturing to ensure cGMP compliance.

The role requires at least 5+ years of GMP/QC laboratory experience and a BS in biology or a related field. Availability for extended hours may be needed to meet deadlines.