QC Specialist

Bayer•Berkeley, CA

13h•Onsite

About The Position

Join our team as a QC Specialist, where you will play a crucial role in conducting chemical and physical analyses in our production site laboratory. Your responsibilities will include performing product release and in-process control tests, conducting stability tests, maintaining and calibrating analytical equipment, managing sample administration in SAP/LIMS, and performing root cause analyses for nonconformities. Additionally, you will support GMP operations through computer system validation, method validation, raw data control and archiving, and the creation of GMP documents and regulations. This position supports the quality control testing of cell therapy, commercial rFVIII, and CCTC products.

Requirements

B.S. in Biological Sciences, Biochemistry, Molecular Biology, Chemistry, or related field
Demonstrated expertise and hands-on experience in flow cytometric assays for characterization of cell therapy products
Thorough knowledge of GLP/GMP guidelines as applied to the testing of biologics molecules
Excellent verbal and written communication skills including writing of scientific and technical reports

Nice To Haves

A minimum of 6 years relevant experience in biopharma, healthcare, or manufacturing environment
M.S. in Biological Sciences, Molecular Biology, Biochemistry, Chemistry, or related field with a minimum of 2 years relevant experience in biopharma, healthcare, or manufacturing environment
Experience in other analytical methods for cell therapy products, e.g., cell-based functional assays, quantitative PCR/ddPCR assays, quantitative imaging assays, virology
Hands-on experience in handling human cells/cell lines including PBMC, CAR-T cells, iPSC
Thorough knowledge of compendial requirements (USP, EP, JP), ACS, and FCC requirements

Responsibilities

Perform GMP analytical testing of cell therapy products, focusing on methods using flow cytometers, microscopic technologies, and ddPCR
Conduct testing of raw materials, starting materials, process intermediates, and final cell therapy products such as CAR-T cells and iPSCs
Provide technical scientific support for QC functional areas, maintaining subject matter expertise for USP/NF, EP, and JP compendia
Follow SOPs accurately, perform activities in accordance with cGMP requirements, and report abnormalities
Execute method validations and transfers, manage discrepancies, and implement corrective and preventative actions
Keep accurate documentation to ensure completeness and accuracy per cGMPs, compile and review data in LIMS or other databases
Demonstrate knowledge of operation, maintenance, and troubleshooting skills for analytical instruments
Independently design and conduct experiments, assays, or operational procedures of considerable complexity
Communicate complex scientific findings and recommendations effectively in various settings
Interact with multiple departments such as Quality Control, Quality Assurance, Supply Chain, Operations, Engineering, Maintenance, and Safety