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Quality Control Analyst
Ref No.: 19-16493
Location: Framingham, Massachusetts
Sunrise System Inc. is currently looking for Quality Control Analyst in Framingham, MA with one of our top client.
Job Title: Quality Control Analyst
Job Id: 19-16493
Location: Framingham, MA 01701
Duration: 6 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: 3 to 6 years
  • Collect and process samples in a timely manner, 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.
  • Perform Water, Steam, and Critical Utility collection as well as associated testing.
  • Perform Biological Indicator Testing.
  • Perform Environmental Monitoring.
  • Perform Endotoxin Testing (Gel Clot and Kinetic Turbid metric).
  • Perform Bioburden Testing of In-Process products, buffers, and water.
  • Receive manufacturing samples into the QC Lab as well as sample retain disposal.
  • Troubleshoot assay and instrument problems with Laboratory Supervisor.
  • Enter and review data in LIMS.
  • Perform safety and operational lab audit.
  • Perform general maintenance of lab equipment.
  • Participate in writing and revisions 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.
  • Perform plate reading, streaking, gram staining, microbial identification.
  • Perform routine Quality Control testing of in-process and final products in a cGMP lab for release.
  • Practice safe work habits and adhere to Genzyme's safety procedures and guidelines. 
Education
  • Basic Qualifications
  • Associates degree in a related discipline and a minimum of 7 years’ industry experience or Bachelor's
  • degree in Life Sciences discipline and a minimum of 3-6 years’ experience.
Preferred Qualifications
  • 3 years’ experience in a cGMP lab environment Working knowledge of Aseptic practices and technique.
  • Proficient in Outlook and MS Work and Excel and lab based data management systems
Skills and Experience
  • ASEPTIC
  • Data Management
  • Excel
  • Life Sciences
  • Outlook 
Additional Skills
  • Quality Control
  • Audit
  • Bioburden
  • CGMP
  • Collection
  • Documentation
  • Environmental Monitoring
  • General Maintenance
  • Inventory
  • Laboratory
  • LIMS
  • LOCKOUT/TAGOUT
  • Maintenance
  • Microbiology
  • Microsoft Excel
  • Microsoft Outlook
  • Operations
  • Optimization
  • Safety Procedures
  • SOPS
  • Staining 
Contact
Bhavani Sangmesh
Direct: (732) 272.0325 | Bhavani.S@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com