Job description

Title: QA Specialist Location: West Point, PA Start date: ASAP Our client is looking for the following: Responsibilities: •Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to provide immediate responses to deviations and potential deviations. •Conducting real time investigations with the goal of fully understanding root cause and product impact within five days of event discovery. •Performing deviation investigations and customer complaints aimed to prevent deviation/complaint re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc • Completing projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and continuous improvement projects that seek to improve yield, reduce cost, or lower our processing cycle times. • Supporting team safety, environmental and compliance objectives. • Managing investigation and complaint timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible. • Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Maintenance, Automation, Technology, Quality, and Planning) • Actively using and championing the use of Lean Six Sigma (LSS) and Merck Production System (MPS) tools, both in problem solving and day-to-day operational activities With the following credentials: Requirements: •B.S./M.S. degree in appropriate engineering/scientific field •Minimum of 0-3 years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry •Previous experience in writing investigations for atypical events in a manufacturing environment •Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities •Demonstrated ability to work both independently and as a part of a cross-functional team •Excellent written and verbal communication skills System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

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