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Quality Assurance Associate

Company: Summit Biosciences Inc.
Location: Stanford
Posted on: February 25, 2021

Job Description:

Responsible for providing quality involvement and oversight for analytical method validation activities.--Audits documentation, records activities, and keeps management informed on quality issues. Essential Duties:-- Supports the development and maintenance of Quality Systems as appropriate. -- Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.-- Assists with the CAPA and Change Control Systems.-- Reviews, and approves cGMP documentation including procedures, validation protocols, development reports, specifications and other related documents. -- Performs activities associated with various one-time or on-going projects (from participation level to project manager).-- Collaborates with departments and external suppliers regarding quality concerns.-- Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.). -- Supports regulatory inspections and customer audits.-- Assists Manager with daily and project activities as needed. -- Other duties as assigned.Qualifications: -- Bachelor degree in a scientific discipline -- At least 5 years cGMP experience -- Knowledge of HPLC principles and ability to review data for accuracy and completeness-- Ability to assess problems, to identify solutions, to plan and implement necessary changes -- Knowledge of cGMP regulations and ICH validation principles-- Ability to work well in a team oriented environment-- Well-developed communication and technical writing skills -- Qualified to work with controlled substances

Keywords: Summit Biosciences Inc., Lexington , Quality Assurance Associate, Other , Stanford, Kentucky

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