Senior QC Analyst: Biopharma & Cell-Based Assays

Avid Bioservices; Tustin (CA); On-site; USD 67,000 - 84,000; Full time

Job summary

Avid Bioservices in California is seeking a Sr. Analyst, Quality Control to support manufacturing, validation, process development and stability studies in a GMP environment.

The role requires strong experience with ELISA and cell-based immunoassays, as well as electrophoresis (SDS-PAGE/IEF). You may lead validation projects and write study protocols, while collaborating across departments to improve QC procedures.

Qualifications

• Bachelor's degree in biology, biochemistry, chemistry or equivalent scientific field.
• Minimum 4 years of hands-on experience in a GMP environment.
• Experience with analytical testing, writing reports/procedures/specifications, GMPs and regulatory audits.
• Strong cell-based assay, qPCR, ELISA, analytical biochemistry and/or chemistry experience.

Responsibilities

• Perform and review routine assays for ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/IEF) per written test procedures.
• Perform aseptic sampling, visual inspection, gowning and clean room work.
• Review, revise and write test methods, SOPs; may lead validation projects, investigations and method development.
• Write study protocols and reports; train other analysts; collaborate on QC procedures.
• Understand and apply company cGMPs and regulatory requirements.
• Participate in regulatory inspections.
• Support continuous improvement initiatives.

Skills

ELISA

Cell-based immunoassays

SDS-PAGE/IEF

qPCR

Analytical biochemistry

Chemistry

Education

Bachelor's degree in biology/biochemistry/chemistry or equivalent

Tools

ELISA equipment

SDS-PAGE

qPCR instruments

Chromatography

Job description

Avid Bioservices in California is seeking a Sr. Analyst, Quality Control to support manufacturing, validation, process development and stability studies in a GMP environment.

The role requires strong experience with ELISA and cell-based immunoassays, as well as electrophoresis (SDS-PAGE/IEF). You may lead validation projects and write study protocols, while collaborating across departments to improve QC procedures.