Posted on: Nov.16.2022
Professional, Continuous Improvement, Sanofi US, Swiftwater, PA, USA
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
Full Job Description
This position within Formulation, Filling, Inspection, and Packaging oversees the revisions, updates, and creation of Quality documents in Geode+, i.e., standalone forms, logbook forms, graphic work instructions, Batch Records, Master Specifications, Standard Operating Procedures, along with other critical documents to maintain the project and commercial production schedules. As part of the organization, this role maintains a strong working relationship with teams: FFIP, QA, APM, and other departments requiring document support through a foundation of trust, accountability, and teamwork.
KEY ACCOUNTABILITIES:
Oversees the authoring of Batch Records, Master Specifications, Standard Operating Procedures, Standard Work Instructions, and other critical documents.
Oversees and provides direction to find resolutions to problems impacting the document process.
Coordinates/tracks all official documentation review and approval workflows within Geode+ ensuring deadlines are met.
Tracks Change Controls and CAPA action items within the Phenix system and are responsible for the closure of deliverables.
Participates in scheduled training and stays abreast of Sanofi's best practices.
Regularly meets with SMEs to determine subject material to be written, regarding documentation and updates.
Manages logbook process (creation, revision, and distribution).
Provides status updates of documents and other quality systems.
Participates as a project core team member that has documented impact.
BASIC QUALIFICATIONS:
Bachelor’s degree from an accredited college or university and zero to three (0-3) years of experience working as a Technical Writer.
PREFERRED QUALIFICATIONS:
Zero to three (0-3) years of experience as a Technical Writer within a Pharmaceutical/Biotech/Medical Device Company
Excellent written and verbal communication skills, as well as the ability to actively and cooperatively work with cross-functional teams.
Attention to detail
Ability to manage conflict and develop customer solutions
OTHER:
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.