Senior Analyst II QC Raw Materials

The role

The Senior Analyst II, QC Raw Materials will support QC Raw Material Program improvements and testing activities. This includes authoring procedures, onboarding materials, conducting risk assessments, and executing daily operations in the QC laboratory.

What you will do

• Support onboarding and qualification of materials and components by creating risk assessments and material specifications.
• Interface with cross-functional stakeholders.
• Own and/or support laboratory deviations, OOS investigations, CAPA, change control.
• Maintains strict adherence to cGMP compliance and all applicable regulations.
• Supports regulatory inspections, external client and internal audits as required.
• Perform QC sample management, testing and release of incoming raw materials, reagents and components.
• Perform routine maintenance of lab equipment as applicable.

Required qualifications

• BS is a scientific discipline with typically at least 4 years’ experience in pharmaceutical/biotech industry.
• Experience with raw material testing programs and quality control methodologies.
• Experience with interpreting and applying compendial test monographs.
• Ability to communicate and work independently with scientific/technical personnel.
• Strong knowledge of GMPs, SOPs and Quality system processes.
• Excellent organizational skills.
• Experience performing laboratory investigations, including out-of-specification investigations.

Nice to have

• Experience in cell and gene therapy manufacturing environment a plus.

About the company

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.