The Quality Assurance Engineer role is responsible for supporting the Quality organization by providing Quality Support on the Production Floor, conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance. The position reports directly to the Quality Assurance Manager at the Noblesville site.

• Quality support on manufacturing floor
• 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.).
• Lead investigator for Out of Specifications results
• Identify and implement Corrective Actions
• 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 federal and international regulations regarding Microbiology, Chemistry and cGMP's
• Provide support for FDA or other regulatory agencies for on-site audits

• Bachelor of Science in Biology, Chemistry or related field required
• 3 or more years of relevant experience required
• Experience investigating exceptions and out of specifications preferred
• Must be able to resolve problems, handle conflict and make effective decisions under pressure
• Root Cause Analysis
• Action oriented/drives for results
• Ability to do simple to complex math calculations, input data into the computer and analyze data as required
• Ability to multitask projects
• 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
• Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing environment

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.