Document Specialist II, Framingham, MA

Job description

Department Description

Document Control ensures cGMP documents used at multiple 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 Genzyme 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.

Position Overview with Key Responsibilities

Facilitate the lifecycle of controlled documents in the electronic document management system (document creation revision, and obsoletion).

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 communications skills in supporting customer and team member needs.

Develop subject matter expertise for all department systems and processes.

Contributor on cross functional project teams.

Basic Qualifications:

High School diploma/GED and 2+ years experience working in a Document Control, Quality Systems, or cGMP environment

Associate's degree with 1+ years experience working in a Document Control, Quality Systems, or cGMP environment

Bachelor's degree with no prior experience.

Preferred:

Strong organizational skills and attention to detail.

Strong written and verbal communications 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.

Experience leading cross-functional project teams.

Special Working Conditions

Ability to lift 20 pounds.

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-SG

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.