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Quality Control Analyst II
Ref No.: 15-03686
Location: Allston, Massachusetts
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 II works independently with minimal 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, participate with the team to meet group goals and perform routine laboratory duties.
 
Skills             
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 Sterility Testing Perform Growth Promotion Testing -Perform Plate Reading
Conduct data analysis based on sample specification Perform safety and operational lab audit
General maintenance of Lab equipment Performing routine QC testing of in-process and final products in a CGMP lab for release.
ELISA testing, container closure testing, particulate testing, HACH, and plate streaking.
Provide training and technical leadership to less experienced staff.
Participate in authoring complex and explicit documentation (Protocols and technical reports).
Involvement in equipment qualification (IQ, OQ, and PQs) and method validation.
            
Education          
Bachelor's and in Life Sciences discipline and 2 years experience in CGMP lab environment
OR
Master's Degree in Life Sciences discipline and 1 year experience in CGMP lab Environment
 
Proficient in Outlook and MS Word and Excel and lab based data management systems

Hours: Friday through Monday 7:00am - 5:30pm