QC Analyst

## QC Analyst Apply:
Swiftwater, PA:
Full time:
Posted Today:
End Date:
October 16, 2026 (30+ days left to apply):
R2870294
*
* Job title:

** QC Analyst
*
* Location:

** Swiftwater, PA
** About the job
** 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.
** About Sanofi
** 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.
*
* Main responsibilities:

**** 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
** Other accountabilities:
*** 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
** Typical

Activities:

*** 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
* Facilitate document review meetings with cross-functional teams
* Maintain document control records and ensure proper version management
* Support regulatory inspections by providing documentation and technical expertise
* Participate in CAPA investigations related to testing or documentation issues
* Monitor documentation metrics and report on completion status
* Train laboratory personnel on new or revised procedures
** About you
**** Key

Qualifications:

*** Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
* 3-5 years of experience in QC laboratory operations. Working in a pharmaceutical environment is preferred.
* Strong understanding of GxP requirements and/or pharmaceutical quality systems
* Experience with…