Quality Control Analyst — GMP Biopharma Testing

avidbio; Costa Mesa (CA); On-site; USD 34,000 - 44,000; Full time

Job summary

Avid Bioservices is seeking an Analyst, Quality Control to join its onsite team in a GMP environment. You will perform testing and sampling to support manufacturing, validation, process development, and stability studies.

The role requires a Bachelor's degree in a scientific field or 2+ years of QC lab experience, with proficiency in ELISA and analytical methods. The position offers traditional M-F hours and potential overtime.

Qualifications

• Bachelor’s degree in biology, biochemistry, chemistry or equivalent scientific field or a minimum of 2 years of relevant, hands-on experience working in a QC or analytical lab or equivalent combination of education/experience.
• Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits are essential.
• Must be proficient with ELISA, Analytical Biochemistry or chemistry.

Responsibilities

• Perform and review routine assays for HPLC, ELISA/cell-based immunoassays, and/or electrophoresis (SDS-PAGE/IEF) with strict adherence to written analytical test procedures.
• Perform aseptic sampling, visual inspection, pH, conductivity, osmolality, and spectrophotometry.
• Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations, and method development projects.
• Other functions include but are not limited to writing study protocols and reports; training other analysts; working with other departments in developing, revising, and implementing QC procedures and policies.
• Knowledgeable of company cGMPs as well as industry regulations that apply to all job functions.
• Participate in regulatory inspections.
• Support continuous improvement initiatives.
• Other duties as assigned.

Skills

ELISA proficiency

GMP knowledge

Regulatory awareness

Documentation writing

Education

Bachelor’s degree in biology/biochemistry/chemistry

2+ years QC/analytical lab experience

Tools

HPLC

SDS-PAGE/IEF

ELISA instruments

Spectrophotometry

Job description

Avid Bioservices is seeking an Analyst, Quality Control to join its onsite team in a GMP environment. You will perform testing and sampling to support manufacturing, validation, process development, and stability studies.

The role requires a Bachelor's degree in a scientific field or 2+ years of QC lab experience, with proficiency in ELISA and analytical methods. The position offers traditional M-F hours and potential overtime.