Address
Form of work Job Title: Quality Control Analyst I
Location: Allston, MA
Duration: 06 Months
Client: Sanofi
Duties
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 andprocess samples in a timely manner, microbiological routine testing of raw materials, in-process, validation samples and finalproducts 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. PerformBradfordProtein Assay .Perform Biological Indicator Testing. Perform Environmental Monitoring. Perform Endotoxin Testing (LAL Gel-Clot and Kinetic Turbidimetric). Perform Bioburden Testing of In-processproducts, buffers, and water Receipt of manufacturing samples into the QC lab as well as sample retain disposal Autoclave.QCmicro equipment Troubleshoot assay and instrumentproblems 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) andproperly 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
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 Must be able to lift 40 lbs Must be able to gown and gain entry to manufacturing areas
Education: Bachelor's Degree in Life Sciences discipline
Location: Allston, MA
Duration: 06 Months
Client: Sanofi
Duties
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 andprocess samples in a timely manner, microbiological routine testing of raw materials, in-process, validation samples and finalproducts 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. PerformBradfordProtein Assay .Perform Biological Indicator Testing. Perform Environmental Monitoring. Perform Endotoxin Testing (LAL Gel-Clot and Kinetic Turbidimetric). Perform Bioburden Testing of In-processproducts, buffers, and water Receipt of manufacturing samples into the QC lab as well as sample retain disposal Autoclave.QCmicro equipment Troubleshoot assay and instrumentproblems 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) andproperly 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
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 Must be able to lift 40 lbs Must be able to gown and gain entry to manufacturing areas
Education: Bachelor's Degree in Life Sciences discipline
