Quality Control Contractor San Carlos, CA 94070 US Posted: 09/05/2024 Employment Type: Contract Job Category: Quality Job Number: 3984 Job Description Our client is looking to add a Quality Control Contractor to their team on a contract basis. You will be assigned to support the daily operations of the Quality Control group, with routine testing and validation activities, while supporting the development of new processes which maximize our technology and enhance our internal and collaborative product development initiatives in a fast-paced environment. The assignment term is six months with a possibility to extend based on business needs. This position is 100% onsite in San Carlos, CA. 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 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 associated 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 2 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. Excellent interpersonal, organizational, written, and oral communication skills. Excellent interdepartmental collaboration skills. Demonstrated expertise with cGMP applicable to pharmaceutical settings and with method verification/validation concepts. Positive team oriented can-do attitude. Ability to operate in a fast-paced laboratory environment and adapt to changing assignments. Apply Now: Apply Online J-18808-Ljbffr