Offers “Sanofi”

Expires soon Sanofi

Principal Investigator

  • Swiftwater, USA
  • IT development

Job description



This is a 1st shift position.

This position is within the Antigen Quality Systems group, and will support Biologics Manufacturing by completing deviation investigations. The candidate will work cross functionally with Operations and various support groups to implement effective and preventative actions as well as performing a thorough product impact assessment.

Key Accountabilities:

·  Authoring and resolution of deviations, change controls, CAPAs, or documents in order to meet production and product release requirements.
·  Identification and facilitation of interdepartmental process improvements.
·  Utilize root cause analysis techniques during deviation investigational process
·  Work cross functionally, to develop and implement continuous process improvements
·  Support production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization.
·  Collaboration with Technical Writers to write, review, revise and prepare manufacturing documents (BPR, SOP, SWI) in accordance with cGMP and regulatory guidelines.
·  Communicate across multiple groups and levels to obtain consensus in order to facilitate deviation closure
·  Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
·  Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.

Basic Qualifications:

·  High School Diploma and 3+ years' cGMP experience.
·  Associates Degree and 2+ years' cGMP experience
·  Bachelor degree and 1+ years' cGMP experience

Preferred:

·  Must have knowledge of continuous improvement techniques and problem solving skills.
·  Previous experience working within a production department of a pharmaceutical company preferred.
·  Candidate must be able 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.

#GD-SP

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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