Sanofi Group Laboratory Coordinator II, Allston, MA in Allston, Massachusetts

This is a 2nd shift position Wednesday to Saturday. The hours are 1:00pm- 11:30pm.

The Quality Control Operations group supports the Quality Control (QC) organization and Manufacturing Operations at Genzyme Allston Landing. QC Operations is responsible for QC department training support, administration of the LIMS system, change control, QC departmental archival of documents, sample receipt, certificate of analysis generation and administration of department metrics and scorecards. It aims to provide timely and dependable operational support to the QC Chemistry, QC Microbiology and QC Validation Support groups on a daily basis to ensure timely and right the first time delivery of test results required by Manufacturing Operations groups and Quality Assurance.

This position is responsible for effectively coordinating documentation, training and samples received in the Quality Control laboratory in accordance with SOP’s.

Responsibilities include:

· Data entry and filing of documentation

· Maintenance of laboratory testing files

· Preparation and maintenance of logbooks used in the Quality Control laboratory

· Performing sample receipt and sample disposal in the Quality Control lab

· Coordinates distribution of samples to other laboratories

· Ordering of laboratory supplies

· Archiving of test records and logbooks

· Manages laboratory reserve samples

· Assisting management/lab personnel with data gathering

· Tracking cycle time performance

Effectively demonstrates an understanding of CGMPs and how it applies to specific responsibilities:

· Following accurate oral and written procedures for maintenance of laboratory

systems, documentation and samples

· Ensures laboratory data and samples are effectively maintained

· Updates laboratory database and tracks the completion of various functions required by the Quality Control laboratory.

· Works independently under general supervision and direction

· Work in compliance with CGMP’s

Practices safe work habits and adheres to Genzyme’s safety procedures and guidelines

Basic Qualification:

  • High School Diploma/GED and 1 year experience in Pharmaceutical Environment

· Microsoft Office

Preferred Qualifications:

· Associates Degree and 1 year experience in an administrative setting Or

· Bachelor’s Degree

· LMS experience

· CGMP experience

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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life