Quality Control Analyst

Our client is looking to add a Sr. QC Associate/Analyst to their team on a contract basis. This is an onsite role in the client’s San Carlos facility.

Responsibilities: 

• Routinely support the plate-based ELISA QC team in ELISA method testing for Antibody Intermediate, troubleshooting, and method lifecycle activities.
• Perform testing of analytical assays including HPLC, CE, icIEF, ELISA, Electrophoresis, UV spectroscopic based methods and compendial methods required for the release and stability testing of antibody intermediates and raw materials. 
• Support Method Transfer and Method Qualification act activities by protocol execution, and protocol/report authorship.
• Perform raw data review, trending and LIMs entry
• Work with QC and AD teams in the completion of critical method optimization activities
• Collaborate with Quality Assurance to review and approve documents associate with all quality control activities. 
• Draft and review QC-analytical documents (SOPs, Protocols, Reports, etc)
• Perform raw material sampling and testing
• Develop and maintain critical reagent inventory necessary to complete analytical quality control activities. 

Qualifications:

• BS in chemistry, biochemistry, bioanalytical chemistry or scientific related field with a minimum of 4 years of industry experience and at least 2-3 years of ELISA plate based assay testing experience
• Demonstrated expertise in the testing of QC Analytical assays for Antibody intermediates, at various clinical or commercial stages
• Extensive knowledge of ELISA and compendial methods. 
• Demonstrated experience in a GMP Quality Control environment.