Quality Engineer - Shirley, NY

Job content

Job Description

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Nature and Scope

The Quality Engineer must demonstrate a sound knowledge, application, and proper implementation of technical, quality, and scientific principals necessary to meet industry and customer requirements. The Quality Engineer has the primary responsibility of providing Quality Assurance input to all aspects of Validated systems.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Preparation/review of Quality Assurance, Validation, and Quality Control protocols and reports covering complex systems such as Process Validation, computer-controlled systems validation, complex utilities, complex manufacturing equipment such as filling systems, formulation systems and knowledge of laboratory validation.
• Works closely with other members of plant quality, manufacturing, calibration services and R&D organizations to accomplish overall objectives; and understand cGMP, and other FDA Guidance Documents, as well as the current processes and practices that are current and ongoing at the American Regent manufacturing/packaging site
• Identify key quality issues and assist their resolution.
• Employ knowledge of process improvement techniques and tools such as the DMAIC model, FMEA, process Flow Diagram, Affinity Diagram, Pareto, Control Charts (SCP) Run Charts, SOP etc.
• Perform any other tasks/duties as assigned by management.
  

Education Requirements And Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Minimum of 3 years in an FDA regulated environment required, preferably in an Engineering or Validation capacity.
• Bachelor’s degree in Engineering or Science, required. Master’s degree preferred.
• Strong working knowledge of cGMP and Federal (FDA) requirements and guidelines.
• Strong technical writing skills and knowledge of Good Documentation Practices.
• Strong knowledge of computer software including Word, Excel, and PowerPoint.
• Ability to interface with senior level employees from multiple departments.
  

Physical Environment And Requirements

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
  

Auto req ID

318644BR

Affiliate Sponsor

American Regent

Minimum Education Required

Bachelors

Job_Category

Engineering

City*

Shirley

State*

New York

Job Code

Quality_Control Quality_Control