Sanofi Group Professional Production Support, Swiftwater, PA - Vaccine in Swiftwater, Pennsylvania
Professional Production Support, Swiftwater, PA - Vaccine
The Professional Production Support role is responsible for ensuring that all document related activities within the Antigen platform are completed compliantly and on time to meet all site objectives and cGMP regulations.
Performs and drives completion of documentation updates within the Quality GEODE+ system.
Edits quality documents (procedures, instructions, specifications, batch records, etc) to ensure compliance with regulatory requirements whether driven administratively or through a Quality system such as Change Control or CAPA
Creates and controls production logbooks (pre, post and during use) and cGMP standalone forms
Maintains document control through production floor support, including but not limited to exchanging inactive official copies of documents for active official copies for documents in real time
Supports production and continuous improvement needs included change control/CAPA implementation as well as operational optimization
Coordinates document revisions and effective dating between multiple groups to ensure a Right First Time environment, open communication and prevention of rework
Ensures cGMP regulations (regarding documents, logbooks, and forms) are adhered to at all times for the Antigen Platform
Maintains and coordinates the Record Retention process of GMP documents for the Antigen Platform. This responsibility includes onsite and offsite record retention.
Bachelor’s Degree and 0-3 years’ experience of Technical Writing or Associates Degree and 2-5 years’ experience of Technical Writing
Working knowledge of cGMP
Proficiency in WORD and EXCEL along with a working knowledge of other MICROSOFT OFFICE programs
Experience within Quality GEODE+ or Documentum related systems as well as Adobe
Meet/Exceed project timelines/deliverables
Experience in document coordination activities
Excellent communication and interpersonal skills (both written and verbal)
Excellent attention to detail and organizational skills
The ability to work on cross-functional project teams
Works quickly with a high degree of accuracy
Continuous improvement techniques and problem solving/analytical skills
Experience writing deviation investigations
Document simplification experience
Experience performing agency inspections
Experience Technical Writing in a science related field
Strength in several CORE Values – Respect, Teamwork, Courage and Integrity
Strength in several LEAD Competencies - Stretch/Take Action/Think Sanofi First
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.
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.
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.