Bioethic
Quality Control Contract Consultant
Bioethic, San Carlos, California, United States, 94071
Quality Control Contract Consultant
Quality
San Carlos ,
California
Contract
May 30, 2024Description
We are looking for energetic and experienced Contract Consultant at our San Carlos, CA site. 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.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 authorshipPerform raw data review, trending and LIMs entryWork with QC and AD teams in the completion of critical method optimization activitiesCollaborate 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 testingDevelop 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 5 years of industry related 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 ELISA, and compendial methods.Demonstrated experience in a GMP Quality Control environment.Excellent interpersonal, organizational, written, and oral communication skills
#J-18808-Ljbffr
Quality
San Carlos ,
California
Contract
May 30, 2024Description
We are looking for energetic and experienced Contract Consultant at our San Carlos, CA site. 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.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 authorshipPerform raw data review, trending and LIMs entryWork with QC and AD teams in the completion of critical method optimization activitiesCollaborate 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 testingDevelop 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 5 years of industry related 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 ELISA, and compendial methods.Demonstrated experience in a GMP Quality Control environment.Excellent interpersonal, organizational, written, and oral communication skills
#J-18808-Ljbffr