Quality Control Microbiology Department supports manufacturing activities at Genzyme Allston
Landing by detecting, quantifying and identifying possible contaminants that may interfere with
the quality of the product during the different stages of the manufacturing process. It aims to
maintain a state of microbiological control in the Utility Systems and within the environment
where the manufacturing process is executed. It assesses the aseptic behavior of the
personnel involved in these processes; and contributes to the guarantee that the end product
will meet the pre-defined standards for safety, purity, identity and effectiveness.
This position is responsible for effectively coordinating documentation, training and samples
received in the Quality Control laboratory in accordance with SOP s.
Skills:Responsibilities include:
Maintenance of SOP User books
Data entry and filing of training 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
Distribution of samples to other laboratories
Ordering of laboratory supplies
Archiving of test records and logbooks
Assisting management/lab personnel with data gathering
Effectively demonstrates an understanding of CGMP s 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
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
Education:High School Diploma/GED and
1 year experience in Pharmaceutical Environment
Attachments: •
Last updated on Oct 12, 2015