Lead QC Analyst — GMP Biopharma: Method Validation & Testing

Avid Bioservices; Tustin (CA); On-site; USD 63,000 - 80,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in California seeks a Lead Analyst, Quality Control to lead testing and sampling for manufacturing, validation, and stability studies within a GMP environment.

You will oversee visual inspections for lot release, method development and tech transfer, and act as SME for multiple testing methods while guiding junior staff. Strong analytical skills and regulatory awareness are essential.

Qualifications

• Bachelor’s degree in biology, biochemistry, chemistry, or equivalent scientific field.
• Minimum 6 years of hands-on experience working in a GMP environment.
• Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits.
• Strong Cell-Based Assay, qPCR, ELISA, Analytical Biochemistry and/or Chemistry experience.

Responsibilities

• Lead and coordinate filled visual inspection for product lot release.
• Lead and execute assay qualification, method validation, special studies, investigations, method development and tech transfer projects.
• Work independently and navigate testing and analytical instrumentation with minimum instruction.
• Act as Subject Matter Expert for multiple testing methodologies and instruments.
• Perform and review routine cell maintenance, cell-based assays, ELISA, SDS-PAGE, immunoblot, and qPCR testing of drug substance and drug products with written procedures.
• Perform aseptic sampling, visual inspection, pH, conductivity, osmolality, and spectrophotometry.
• Provide guidance to Jr. Analysts and Analysts regarding lab work.
• Review, revise, and write test methods, SOPs and may perform trending analysis.
• Write study protocols and reports; train other analysts; collaborate with other departments in developing, revising, and implementing QC procedures and policies.
• Stay abreast of company cGMPs and applicable industry regulations.
• Participate in regulatory inspections.
• Actively participate in departmental continuous improvement efforts.

Skills

Cell-based assays

qPCR

ELISA

Analytical testing

GMP experience

Technical writing

Education

Bachelor's degree in biology/biochemistry/chemistry

Tools

SDS-PAGE

Spectrophotometer

qPCR instruments

Job description

Avid Bioservices in California seeks a Lead Analyst, Quality Control to lead testing and sampling for manufacturing, validation, and stability studies within a GMP environment.

You will oversee visual inspections for lot release, method development and tech transfer, and act as SME for multiple testing methods while guiding junior staff. Strong analytical skills and regulatory awareness are essential.