Sr. Analyst, Quality Control

Avid Bioservices•Tustin, CA

19h•Onsite

About The Position

Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. The Sr. Analyst, Quality Control will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment. This position requires a strong background in ELISA/cell-based immunoassays and electrophoresis (SDS PAGE/IEF) and supports/leads continuous improvement initiatives.

Requirements

Bachelor’s degree in biology, biochemistry, chemistry, or equivalent scientific field.
Minimum 4 years of relevant 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.

Nice To Haves

Experience with cell-based assays, qPCR, electrophoresis, chromatography, aseptic techniques, and assay validation/qualification.

Responsibilities

Perform and review routine assays for ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/IEF) with strict adherence to written analytical test procedures.
Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
Review, revise and write test methods, standard operating procedures and may perform trending analysis.
In addition to performing QC testing, the Analyst may be designated as study Lead for validation projects, investigations and method development projects.
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.
Participates in regulatory inspections.
Support continuous improvement initiatives.