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Quality Control Analyst I
Ref No.: 15-03662
Location: Allston, Massachusetts
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 individual will report to the QC shift Supervisor in the Allston Quality Control laboratory and will contribute to general operations and testing of the QC Microbiology laboratory. QC Analyst I works independently under general supervision. Primary responsibilities include, but are not limited to the following: collect and process samples in a timely manner, microbiological routine testing of raw materials, in-process, validation samples and final products in accordance with SOPs and CGMP regulations; review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.

Skills
Major Responsibilities may include but are not limited to:
Critical Utility collection and testing
Biological Indicator Testing
Environmental Monitoring
Endotoxin Testing
Bioburden Testing
Receipt of manufacturing samples into the QC lab as well as sample retain disposal Autoclave QC micro equipment Troubleshoot assay and instrument problems with Laboratory Supervisor Enter and review data in LIMS Perform safety and operational lab audit General maintenance of Lab equipment Writing and revising SOPs, protocols Maintain log books Ensure labs are clean and safe (in compliance with CGMP) and properly stocked Make detailed observations in support of Alert, Action and OOS result investigations Qualification of equipment, methods, and processes Special studies & projects assigned to microbiology

Education
BASIC QUALIFICATIONS:

Bachelor's Degree in Life Sciences discipline No prior industry experience required Microsoft Office

PREFFERED QUALIFICATIONS/SKILLS:

1 Year Experience in a CGMP lab environment Proficient in Outlook and MS Word and Excel and lab based data management systems Experience with environmental monitoring including water testing