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Senior Specialist Q. A - Level I (BCG ONLY)
Ref No.: 24-88831
Location: Durham, North Carolina
Start Date / End Date: 07/15/2024 to 07/15/2025


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.

Quals--
Quality Assurance professional with a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 1-3 years’ experience in the Pharmaceutical Industry. 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, LEL/Endotopin testing experience, Process monitoring also preferable skillsets. Have had success with candidates who worked at Pharmaceutical in the past. Will work on a team of about 12. A mix of individual tasks but also working together as a holistic team. Strive for attention to detail, team player. Shift is mostly days but can include an early morning or later shift from time to time. **Two positions. Sun-Thurs shift and Tues-Sat shit (please put shift availability on resumes).