Quality Control Analyst I - OQSIE
Allston, MA
About the Job
Performs operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provides an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Completes routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aids in the development of test methods. Conducts data review and preliminary evaluation of results. Solves problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provides input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group. Experience: 0 to 3 years.
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.
Tuesday-Friday 0600-1630
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
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
*Position will rotate Saturday coverage once trained on required assays
Special Working Conditions:
Must be able to lift 40 lbs
Must be able to gown and gain entry to manufacturing areas
Must be able to work with Spor-Klenz solution, which is used to sanitize equipment
Must be able to work on flexible schedule on a periodic basis based on business needs
Position is considered essential personnel and may be required to staff the lab during inclement weather events
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.
Tuesday-Friday 0600-1630
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
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
*Position will rotate Saturday coverage once trained on required assays
Special Working Conditions:
Must be able to lift 40 lbs
Must be able to gown and gain entry to manufacturing areas
Must be able to work with Spor-Klenz solution, which is used to sanitize equipment
Must be able to work on flexible schedule on a periodic basis based on business needs
Position is considered essential personnel and may be required to staff the lab during inclement weather events
Source : OQSIE