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Records Mgment Associate Senior Job at Quality at Sanofi

Location Framingham, Massachusetts Job Category Quality Requisition Number POS_00474971-1
Records Mgment Associate Senior-POS_00474971-1

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Genzyme Corporation (a Sanofi company) 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.

Records Management ensures that cGMP records used at Framingham are managed and protected during their lifecycle (issuance, reconciliation, archival and destruction) in compliance with business needs and regulatory expectations. The overall goal is to ensure that record management policies, procedures, and processes meet applicable regulations. Additionally, record management provides lifecycle guidance to records users.

Position Summary
The Records Management Specialist is responsible providing Records Management related quality support and guidance to ensure continued compliance to cGMP and company expectations.

Core Responsibilities
• Perform record issuance and reconciliation activities.
• Interact/update/maintain the record management database.
• Perform record management database administration.
• Initiate/perform periodic record audits.
• Perform gap analysis of Records Management site procedures against company Standards, Directives, and Guidance’s and update site procedures accordingly.
• Point of contact for customer record management discussions.
• Point of contact for record off-site storage and retrieval,
• Interact/update offsite records management vendor database.
• Initiate/perform record destruction.
• Update Records Management procedures.
• Generate departmental metrics.
• Initiate Records Management related change controls.
• Initiate Records Management related deviations and CAPA.
• Work with customers to discuss/develop new Records Management related processes/efficiencies.
• May provide shadowing or mentoring training to new employees.
* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs

• High school degree or 4-6 years’ experience in Quality or Operations experience in a cGMP environment.

• Demonstrated experience in Records Management or Document Control.
• Bachelor’s degree with 3 years’ experience in a cGMP environment.
• Understanding and experience with input and retrieval of data in database or spreadsheet
• Experience in leading teams and projects.
• Experience mentoring and developing employees.
• Industry bio-pharmaceutical experience.
Demonstrated experience with Word ® and Excel ®
• Effective verbal, and written communication skills.
• Strong attention to detail skills.
• Effective time management, organizational skills, teamwork and collaboration.
• Significant problem solving methodology.
• Ability to work independently.

Job : Quality
Primary Location : United States-Massachusetts-Framingham

Job Posting : Jun 8, 2016, 10:39:12 AM

Job Type : Regular
Employee Status : Regular