Senior Specialist Q. A Level I
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![]() United States, North Carolina, Durham | |
![]() 5325 Old Oxford Road (Show on map) | |
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Position Title: Senior Specialist Q.A - Level I Work Location: Durham, NC 27712 Assignment Duration: 12 months Work Schedule: Mostly days but can include an early morning or later shift from time to time Position Summary: Responsible for quality assurance oversight in the manufacture and testing of sterile pharmaceutical products. Qualification & Experience: * Quality control professional with a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 1-3 years' experience in the Pharmaceutical Industry preferred, High school acceptable with equivalent experience and open to advanced degrees. * Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing. * Experience with environmental monitoring is TOP skillset. * Water sampling/filtration experience, utility monitoring, and aseptic technique heavily preferred. * SAP and/or GLIMS experience are nice to have skills. * Previous gowning experience, LAL/Endotoxin testing experience, Process monitoring also preferable skillsets. * Have had success with candidates who worked at our organization in the past. * Will work on a team of about 19. * A mix of individual tasks but also working together as a holistic team. * Strive for attention to detail, team player. Key Responsibilities: * Responsible for environmental monitoring in aseptic environment, collection and processing of water samples, component and product release testing. * Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. * Must have very strong relationship building skills. |