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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