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Quality Assurance Associate

Company: Impellam Group N.A.
Location: Durham
Posted on: April 10, 2021

Job Description:

SRG is seeking a Quality Assurance Associate for a client in Raleigh, NC.This position is with a growing biotech company and qualified candidates will have a BS degree and 4+ years of related biotech/pharma industry experience. Responsibilities:* Provide support for deviation management for facilities/utilities programs and calibration exceptions* Provide support for other Quality Systems such as change control, microbiology laboratory, manufacturing sciences & technology and validation support* Support quality programs/systems governing deviations* Compliance review and approval of relevant GMP documents, deviations, CAPAs, change-controls, facilities/utilities, and CMC documentation as needed* Author and review SOPs as required for QA. * Support site operations during internal audits, regulatory agency and third-party inspections.* Participate as quality assurance representative on cross-functional teams and projects.* Collect and analyze data supporting goals and department metrics.Qualifications:* BS/BA in a scientific/engineering field* 4+ years of pharmaceutical industry experience* Broad experience with cGMP manufacturing operations and calibration/metrology* Knowledge and experience with deviation, CAPA, calibration, validation document review and approval.* Experience with Microsoft Dynamics 365 or other ERP system.* Experience with MasterControl, LIMS, Trackwise.SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

Keywords: Impellam Group N.A., Durham , Quality Assurance Associate, Other , Durham, North Carolina

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