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Sanofi Group Principal Investigator in Swiftwater, Pennsylvania

This is a 1st shift position.

This position is within the Antigen Quality Systems group and supports Biologics Manufacturing primarily through completion of deviation investigations. The candidate will work cross-functionally with Operations and various support groups to investigate root causes, implement effective corrective and preventative actions, and perform thorough product impact analyses.

Key Accountabilities:

  • Authoring and resolving deviations, change controls, CAPAs, and documents in order to meet production and product release requirements.

  • Communicating across multiple groups and levels to drive deviation closure.

  • Identifying interdepartmental process improvements and working cross-functionally to-implement them.

  • Utilizing root cause analysis techniques and technical impact analyses during the deviation investigation process.

  • Collaborating with Technical Writers to write, review, revise and prepare manufacturing documents (BPR, SOP, SWI) in accordance with cGMP and regulatory guidelines.

  • Managing multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization

  • Communicating (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.

Basic Qualifications:

  • A High School Diploma and 3+ years’ cGMP experience. OR

  • An Associate’s Degree and 2+ years’ cGMP experience OR

  • A Bachelor’s degree and 1+ years’ cGMP experience

Preferred Qualifications:

  • Knowledge of continuous improvement techniques and problem-solving skills.

  • Previous experience working within a production or quality department of a pharmaceutical company preferred.

  • Ability to work extended and flexible hours (including weekends) when needed.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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