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Aerotek FULLY REMOTE- QA Systems Associate GxP in New York, New York

About Company:

Biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases

Location: Fully Remote

Education : Bachelor’s degree in chemistry or related scientific discipline with at least

Qualifications:

o BSc/BA in Organic Chemistry, Biochemistry, Applied Biology, Pharmacology or a relevant science

o 5 years of pharmaceutical drug QA experience, specifically in quality system operations.

o Fluent in English, both spoken and written

Description:

This position is responsible for maintaining and improving Intercepts Quality Management Systems with respect to Product Quality Complaints, Deviations, QEs/CAPAs, Change Controls and Document Management. The role itself is holistic in nature and knowledge about all aspects of Quality Systems and their interactions with various GxPs is expected.

• Liaise with Intercept QA and other departments to maintain compliance to the Intercept Quality Systems, specifically:

o Oversee Change Control process through the entire change life cycle.

o Aid in review and completion of product quality complaints.

o Facilitate Quality Event and CAPA review sessions, actively follow up on overdue deviations.

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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