Quality Control Analyst - Microbiology - Thursday - Monday NIGHT SHIFT at Allston

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** This position requires working the following schedule: Thursday to Monday 9:00PM to 7:30AM **

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 Third 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. Major Responsibilities and testing may include but are not limited to:

• Perform Water, Steam and Critical Utility collection as well as associated testing
• Perform Biological Indicator Testing
• Perform Environmental Monitoring
• Perform Endotoxin Testing (LAL Gel-Clot and Kinetic Turbidimetric)
• Perform Bioburden Testing of In-process products, buffers, and water
• 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
• Participate in writing and revising SOPs, protocols
• Assist in the development and optimization of testing methods
• Maintain log books related to inventory and equipment
• 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
• Participate in the qualification of equipment, methods, and processes
• Participate and perform special studies & projects assigned to microbiology
• Perform other additional job related duties as required

BASIC QUALIFICATIONS:

• Bachelors 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

SPECIAL WORKING CONDITIONS:

• Must be able to lift 40 lbs
• Must be able to gown and gain entry to manufacturing areas. M*

Country: USA, State: Massachusetts, City: Allston, Company: Genzyme Corporation.