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Quality Control Analyst

Harmans, MD

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Description

Quality Control Analyst

Harmans, MD

Remedy Intelligent Staffing is looking for Quality Control Analysts. This role focuses on the transfer/qualification/Validation of GMP biologic assays such as ELISA, qPCR, RT-PCR, HPLC and Capillary Electrophoresisis.

This is a temp-to-hire position with a global pharmaceutical company with a branch in Harmans, MD.

Shift: Monday – Friday 8:00 am – 5:00 pm

Pay Rate: Depends on Experience 

In this position you will:

  • Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis.
  • Generate internal and external documents such as assay protocols, summary reports, and SOPs.
  • Assist with investigations related to assay performance. Work on project teams developing and improving assays.
  • Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns.
  • Provide instrumentation care, maintenance, troubleshooting, and data interpretation.
  • Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured.
  • Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.

For this position you need:

  • Bachelor in a Science discipline and 4-6 years of experience working in a GMP Quality Control Lab with some or all of the time working with method transfer & qualification.
  • Considerable knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology.
  • Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices.
  • Experience in writing SOPs and test methods as well as method qualification/validation documentation.
  • Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work.
  • Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks.
  • Ability to succeed in a team-oriented environment under very dynamic conditions.

What you can get:

  • Weekly pay
  • Medical benefits

Members of the Military and Veterans encouraged to apply!

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