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Quality Engineer/ Biochemist

Posted about 1 month ago

Position: Quality Engineer/ Biochemist
Location: Newark, DE 19702
Term: 12 months
 
Day-to-Day Responsibilities:
  • Responsible for laboratory testing on instruments, troubleshooting, and test process changes.
  • Laboratory Testing will include and is not limited to: Performing test methods on various chemistry, analytical and diagnostic equipment. Strong knowledge of GLP and GDP as per clinical chemistry practices.
  • Instrument Systems maintenance and Testing will include and are not limited to: Dimension, Dimension Vista, Atellica, Stratus CS, and Cobas. Additional familiarity a plus: Advia, Centaur, Immulite.
  • The instrument information system will include and is not limited to: hard/software relative to LIMS and troubleshooting of laboratory systems.
  • Process changes will include and are not limited to: documentation, work instruction, qualification, validation, failure mode analysis, software, and process validations.
  • Analytical Testing: Understands Quality Control, Testing, Chemistry, and Biology as pertains to the diagnostics industry.
  • Completes manufacturing-related testing and processes for Diagnostic equipment and analyzers.
  • Leads the most complex quantitative and qualitative analysis, such as sampling, testing, and measuring using complex equipment.
  • Enters data into internal computer systems and generates documents as required.
  • Learn and follow the Quality Change Process required in the Quality Control and Operations area.
  • Develops, recommends, and implements technical documentation changes to meet regulatory quality requirements and SAP-based manufacturing system needs.
  • Identifies problems as they occur and takes appropriate steps to solve them.
  • Flexibility to work overtime and/or irregular work hours as needed.
  • Formatting, writing, and editing of very complex technical documentation
  • Plan, author, document, and execute projects.
 
Is this a good fit? (Requirements):
  • Bachelor of Science or equivalent degree with 2-7 years experience in a relevant field with basic Chemistry/Biochemistry or Medical Technologist background.
  • Experience with LIMS and information systems.
  • Strong computer skills in the knowledge of Microsoft Word and Excel, and macros.
  • Knowledge of FDA-regulated environment and ISO/IVDD standards.
  • Familiar with GMP, GLP, and GDP processes.
  • Knowledge or familiarity with the SAP production system.
  • Knowledge of Lean Manufacturing, Continuous Improvement, Six Sigma, and the various tools.
  • Strong communication and interpersonal skills.
  • Able to work independently, and on a team and be able to multi-task and prioritize daily work.
  • Background in production processes relative to chemical and physical chemistry, concentration calculations, and statistics.

 

Candidates will be responsible for following the client's COVID-19 protocols. Please refer to your MATRIX representative for specifics.

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