QC Analyst

Job title: QC Analyst

Location: Swiftwater, PA

About the job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In 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 analytical testing methods and equipment

• Proficiency in document management systems (e.g., QualiPSO, electronic document management systems)

• Knowledge of test data review processes and data integrity principles

• Experience coordinating documentation workflows and managing stakeholder reviews

• Excellent attention to detail and organizational skills

• Strong written and verbal communication skills

• Knowledge of iShift functionality and navigation is preferred

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. 

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. 

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.