Document/Training Coordinator - Vaccine

Document/Training Coordinator - Vaccine

The Quality Validation Professional provides training and document control support to the Quality Validation function ensuring that all activities are completed on time to meet site objectives and in compliance with all company procedures and cGMP regulations.

KEY RESPONSIBILITIES:

• Develops, updates, and maintains training materials

• Authors Documents, Change Controls, CAPAs

• Creates and controls logbooks and forms both paper and electronic

• Maintains and coordinates the Record Retention process of GMP documents for validation

• Acts as Subject Expert on functional area application systems, such as Learning Management System, Electronic Document Management systems, providing assistance and training to end-users

• Tracks and reports actions within Quality Systems (e.g., Change Controls, CAPAs, Deviations, Internal Audits)

• Generates Quality Validation metrics

BASIC QUALIFICATIONS:

• Bachelor’s Degree and 0-3 years’ experience in Technical Writing or cGMP environment

• Associates Degree and 2-5 years’ experience in Technical Writing or cGMP environment

• In lieu of a degree, 8+ years’ experience in Technical Writing or a cGMP environment 

PREFERRED COMPETENCIES:

• Excellent communication (written and verbal) and interpersonal skills

• Excellent organizational skills

• Experience in document coordination activities

• Works efficiently with a high degree of accuracy

• Meets/exceeds project timelines/deliverables

• Proficient in Word, Excel, PowerPoint, SharePoint, and Teams

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.

Fully vaccinated, 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.