Quality Control Contract Consultant

Bioethic; San Carlos (CA); On-site; USD 100,000 - 125,000; Full time

Job description

Quality Control Contract Consultant
Quality San Carlos ,  California Contract May 30, 2024

Description

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 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 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