QC Analyst

Job title:

QC Analyst

Location:

Swiftwater, PA

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

We are Sanofi. Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career.

We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.

• Test Data Review:
  Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified
• Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans
• Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Support root cause analysis investigations for testing deviations
• Document coordination:
  Coordinate quality control documentation lifecycle activities
• Manage document workflows, including review, approval, and distribution processes
• Ensure documentation compliance with good documentation practices (GDP)
• Create, maintain, and update QC technical documentation and SOPs
• Monitor document revision schedules and coordinate periodic reviews
• Liaise with subject matter experts (SMEs) for document content development
• Support metadata management and document control activities in quality systems (e.g., QualiPSO)
• Coordinate stakeholder reviews and consolidate feedback

• Executing assigned CAPAs related to remediation plans, continuous improvements
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately
• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements
• Supporting laboratory and deviation investigations

• Review test data for accuracy, completeness, and compliance
• Coordinate the creation, review, and approval of QC SOPs and technical documents
• Manage document change requests and assess impact on testing operations