Supplier Quality Engineer

Summary of Position

This role is located at our Noblesville, IN facility and is responsible for supporting the Quality Systems organization through conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.  

Work Schedule: Monday – Friday 8am – 5pm  
 

Essential Functions

• Support and serve as investigator for Out of Specifications results.   
• Identify and implement Corrective Actions. 
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.). 
• Support or serve as lead investigator for Exceptions to Standard Operating Procedures. 
• Generate or review Change Controls for Standard Operating Procedures, Standard Test Methods, Data Sheets, etc. 
• Employ the use of quality tools (i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) in support investigations and special projects. 
• Perform statistical analysis of laboratory data in support of investigations, cost savings, continuous improvement initiatives. 
• Generate, execute and manage protocols for Method Validations, Equipment Qualifications Work with radioactive materials. 
• Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP’s. 
• Maintain current knowledge of US and international regulations regarding Microbiology, Chemistry and cGMP's. 
• Provide support for regulatory agency (i.e. FDA, HC, EU, TGA, etc.) on-site audits. 
   

Requirements

• Bachelor of Science degree in Life Sciences or Engineering required, or equivalent experience.  
• Three or more years of relevant experience in a pharmaceutical/medical device manufacturing environment with strong understanding of and exposure to applicable quality systems required.  
• Working knowledge of cGMP guidelines and their application in a controlled aseptic environment preferred.  
• Must have awareness of quality systems including Change Control, Internal Auditing, Corrective Action Program, Deviation and Complaint investigations, and Document Management. 
• Must have experience with statistical tools.   
• Ability to do simple to complex math calculations, input data into the computer and analyze data as required. 
• Must be proficient in use of Microsoft suite office products; Good computer skills, including utilizing personal computers and data entry programs. 
• Good hands on, analytical, and problem solving and decision-making skills. 
• Excellent writing and verbal communications skills. 
• Ability to work independently and with others to accomplish goals and priorities. 
• High level of energy and regular, consistent attendance. 

Working Conditions: 

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. 
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.   
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury. 
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed. 
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.   
• Must possess good hand-eye coordination; close attention to detail is required. 
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.  
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment. 
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.