Quality Assurance Engineer

Summary of Position

The Quality Assurance Engineer is responsible for supporting the Quality organization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.

Work Schedule: Saturday – Wednesday 12:00am – 08:30am, Training period will be on 1st shift Monday – Friday, with occasional weekends. Schedule is subject to change.

Essential Functions

• Identify and implement Corrective Actions Investigate Exceptions (Deviations).
• Generate or review Change Controls for Batch Records, Standard Operating Procedures, Standard Test Methods, Specifications, 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 analysis of data in support of investigations, cost savings, continuous improvement initiatives 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 quality regulations
• Author or perform peer review of annual product quality reviews.
• Provide support for regulatory agency (i.e. FDA, HC, TGA, EU, etc.) on-site audits, as required.
• 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.).

Requirements

• Bachelor of Science in Biology, Chemistry or related field required. Work experience is considered in lieu of degree.
• 3 or more years of relevant experience required.
• Must be able to resolve problems, handle conflict and make effective decisions under pressure.
• 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.