Position Overview:

The QC Senior Analyst, Raw Materials will support QC Raw Material Program and Testing activities, including onboarding materials, conducting raw material risk assessments and execution of daily operations in the QC laboratory. This position is responsible for QC sampling, testing and release of incoming raw materials, components and biological materials used in the production process per established procedures. The role will also support oversight and review of contract testing of raw materials.

Responsibilities:

• Perform QC sampling, testing and release of incoming raw materials, reagents and components.
• Support onboarding and qualification of materials and components by creating risk assessments and material specifications.
• Interface with cross-functional stakeholders, including Supply Chain, Manufacturing, Manufacturing Sciences & Technologies, Process Development and Analytical Development.
• Performs routine maintenance of lab equipment as applicable.
• 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.

Qualifications:

• BS is a scientific discipline with 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 in cell and gene therapy manufacturing environment a plus.
• Experience performing laboratory investigations, including out-of-specification investigations.