(Contractor) Quality Assurance Engineer

Curium Pharma • Noblesville, IN

13d

About The Position

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 (Contractor) 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: Monday - Friday 8am - 4:30pm

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.

Responsibilities

• 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.).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level