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Quality Control Analyst III – Next Generation Sequencing

LGC Clinical Diagnostics Division
Job Location
910 Clopper Road
Gaithersburg, MD 20878
United States

Medical/Dental/Vision/401K and much more!

Job Description

Job Purpose: Advance LGC's purpose of understanding disease and delivering science for a safer world.  The QC Analyst III will contribute to a highly motivated and cohesive internal QC testing team that functions to support manufacturing with timely and accurate in-process and final product testing.

Key Responsibilities

  • Perform Next Generation Sequencing library preparation and sequencer loading.
  • Perform NGS data analysis.
  • Perform nucleic acid extractions and assays (RNA/DNA integrity analysis, real time qPCR, digital PCR) and analyze results.
  • Work with supervisor to plan and execute new assignments according to required timelines and ensure documentation meets GLP/GMP requirements.
  • Maintain, calibrate and operate equipment according to established protocols. Monitor equipment for appropriate operation within set parameters and refer abnormal results to lab management.
  • Work in collaboration with the Quality Assurance group to fulfil Quality Management Goals and proactively address problems under an ISO quality system.
  • Plan for raw material requirements by maintaining appropriate inventory of reagents and ordering reagents as needed through an ERP system (SAP).
  • Maintain a clean and safe lab environment.

Knowledge, Experience and Technical Skills

  • Critical thinker who can analyze data and provide summary analysis to management.
  • Ability to manage and complete assignments on time and in appropriate order.
  • Capability of working with multiple departments to achieve department and site objectives.
  • Ability to work independently with minimal supervision.
  • Strong organizational skills
  • Engaged and committed team professional
  • Passion for continuous improvement
  • Collaborates effectively with others
  • Independent thinker and self-learner

Education and/or Experience

  • Bachelor’s degree in science or related field.
  • Must have minimum of 2 years’ library prep and NGS experience.
  • Experience operating and maintaining Illumina sequencers analyzing NGS data.
  • Experience with various DNA and RNA extraction methods is preferred.
  • Must be a positive team player with excellent interpersonal skills.
  • Experience in writing and executing protocols is preferred.
  • Software experience: Excel, Word and PowerPoint. Knowledge of any programming language preferred.
  • Analytic skills: Perform preliminary data interpretation/analysis. Follow SOPs.
About Our Organization

LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results. Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and the Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.   Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

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