(Contractor) Senior Quality Assurance Engineer

(Contractor) Senior Quality Assurance Engineer Date: Oct 4, 2024 Location: Noblesville, IN, United States About Curium Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team. Summary of Position The Senior Quality Assurance Engineer is responsible for the Quality oversight for Validation, Engineering and Maintenance at the site. This position requires strong technical and quality skills. The position reports directly to the Senior Manager or Senior Director of Quality Assurance. Knowledge in pharmaceutical quality systems with proficiency in quality oversight of: Validation, Engineering, Maintenance, Manufacturing, QC, Regulatory, CAPA, Deviations, Out of Specification Investigations, and Annual Product Reviews. Work Schedule: Monday - Friday 8am - 5pm Essential Functions Take a lead role for site/corporate development and maintenance of facility's quality systems and procedures. Review and approve Change Control/Process Management Documents involving product or process changes. Key personnel for FDA or other regulatory agencies for on-site audits. Reviews and approves IOQs, requirement documents, SOPs, validation documents and data integrity assessments. Assemble, analyze and report QA system data to ensure regulatory compliance, identify trends and to identify areas of improvement. Conduct quality audits and develop and assess subsequent corrective action recommendation(s). Developing procedures, statistical evaluations, and remediation of systems. Ability to adapt quickly in a fast-paced dynamic environment. Ability to communicate with and positively influence broad and diverse populations within and outside the organization. Ensure a safe and quality working environment through training, awareness and compliance to safety guidelines and SOP's. Ensure the maintenance of the department, premises and equipment. Additional areas of responsibility may include developing specifications, standard operating procedures; providing quality system training and actively participating in Quality Review Board meetings. 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, Life Sciences or related field required Five or more years of relevant Quality or Validation experience in a finished pharmaceutical manufacturing environment with strong understanding of and exposure to applicable quality systems. Experience in supporting on-site inspections for regulatory agencies. Significant experience investigating Deviations and other variances. Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems. Working knowledge of cGMP guidelines and their application in a controlled aseptic environment Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcome. Must have experience with statistical tools Proficient in use of Microsoft suite of products. 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, 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 mehanical/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. Competencies ANALYZE ADAPT COMMUNICATE EFFECTIVELY DEVELOP SELF OTHERS INTERNAL/EXTERNAL CUSTOMER-FOCUSED RESULTS-DRIVEN Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Equal Opportunity Employer Curium is anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Job Segment: QA Engineer, Quality Engineer, Facilities, Nuclear Engineering, QA, Engineering, Operations, Quality