Documentation Specialist

Job Title

Documentation Specialist

Location

Swiftwater, PA

About The Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Document Control ensures cGMP documents used at multiple Sanofi Genzyme manufacturing sites are correct, consistent, and functional. The Document Control team also maintains master versions of SOPs, production and control records, and facilitates associated life-cycle activities in compliance with Sanofi standards. Document Control creates and presents training and provides guidance to documentation systems users. The department objective is to adhere to the highest quality and safety standards while supporting the multi-faceted needs of a fast-paced and deadline driven organization.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

• Facilitate the lifecycle of controlled documents in the electronic document management system (document creation, revision, and obsoleting) Prepare the daily workplan
• Create and Issue Logbooks
• Print and Issue Batch Records, Addition
• Attend +QDCI and team board meetings
• Execute cGMP standard operating procedures while adhering to all company quality standards and requirements
• Assess for accuracy and process document Change Request workflows
• Demonstrate expertise in Microsoft Word and other Microsoft Office applications to meet established document formatting requirements
• Execute supplementary cGMP department activities in support of site operations
• Exercise professional written and verbal communication skills in supporting customer and team member needs
• Contribute on cross functional project teams

About You

Basic Qualifications

• High School Diploma/GED and 3-4 years working in Document Control, Quality Systems, or other cGMP environment or bachelor’s degree with no prior experience

Preferred Qualifications

• Strong organizational skills and attention to detail
• Strong written and verbal communication skills
• Team oriented and customer friendly
• Proficient in Microsoft Word
• 2-3 years’ experience using electronic document and records management systems
• 2-3 years’ experience working in a cGMP environment

Special Working Conditions

• Ability to handle/move documentation boxes, file records into shelves and documentation boxes.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.