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Quality Assurance Specialist

Quality Assurance Specialist

AllSTEM ConnectionsDurham, NC, US
1 day ago
Job type
  • Full-time
Job description

Job Title : Quality Assurance Specialist

Duration : 2 years

Location : Durham NC

Description :

Education / Experience Requirements

  • Associate's degree in Biology, Microbiology, Biochemistry, or related field plus 1-2 years of relevant laboratory / pharmaceutical experience
  • Bachelor's degree in Biology, Microbiology, Biochemistry, or related field

Required Experience and Skills

  • Understanding and application of Good Laboratory Practices and cGMPs
  • Aseptic technique
  • Performance of environmental and water systems monitoring
  • Working in a team environment

    • Preferred Experience and Skills

  • Strong verbal and written communication skills
  • Experience with LIMS, SAP or other laboratory / production software systems

    • The main function of the Associate Specialist, Quality Control is to assist in the assurance of the quality of product through the performance of microbiological, chemical and analytical sampling and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources, as necessary to support Manufacturing.

    Responsibilities

    General

  • Conducts release testing in support of finished product
  • Conducts microbiological testing; evaluation of environmental microbiological samples
  • Conducts environmental monitoring sampling to include active air and surface sampling and water sampling
  • Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects
  • Maintains lab materials and reagents

    • Business & Functional Expertise

  • Completes assignments in alignment with department objectives
  • Conducting In-Process and Release testing
  • Conducting Environmental Monitoring of processes and on a routine basis
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