Quality Assurance Specialist (Durham)

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