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Quality Control Analyst
Ref No.: 20-02110
Location: Allston, Massachusetts
Sunrise System Inc. is currently looking for Quality Control Analyst in Allston, MA with one of our top client.
 
Job Title: Quality Control Analyst
Job Id: 20-02110
Location: Allston, MA 02134
Duration: 5 months
Position Type: Hourly contract Position (W2 only)
 
Duties
  • 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 Turbid metric)
  • 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
Education
  • BS or MS in Life Sciences (Biology or Microbiology or similar) Preferred Qualifications:
  • 1 Year Experience in a CGMP lab environment Proficient in Outlook, MS Word, Excel and lab based data management systems Experience with environmental monitoring including water testing
Skills and Experience
  • CGMP
  • Collection
  • Water Testing
  • Documentation
  • Laboratory 
Additional Skills
  • Life Sciences
  • Microbiological
  • Microbiology
  • Quality control
  • SOPS
  • ASEPTIC
  • AUTOCLAVE
  • BIOBURDEN
  • Data Management
  • Environmental Monitoring
  • Excel
  • General maintenance
  • Inventory
  • LIMS
  • Maintenance
  • Manufacturing Process
  • Microbiology Laboratory
  • Microsoft Excel
  • Microsoft Outlook
  • Microsoft Word
  • MS Word
  • Operations
  • Optimization
  • Outlook
  • Word 
Contact
Pooja Sinha
Direct: (732) 272 - 0316 | Email: pooja.s@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com