Senior Specialist Q. A Level I

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.