Are you looking to be part of a game-changing organization that is helping thousands of patients across the country every day? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team in Beloit, WI or Madison, WI.
NorthStar develops, manufactures, and distributes radioisotopes used daily for patients needing medically important diagnostic imaging tests. Using novel and advanced technologies, NorthStar will scale-up production over the coming months and years and intends to become the industry’s market leader.
Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.
The Technical Writer will draft or assist with the creation of production process documentation, as related to the development of novel radioisotope processing systems. This documentation will be in the form of operator work instructions, batch production records and other associated production procedures. All associated documentation will be updated throughout the development, verification and validation processes, as related to systems used in the production of pharmaceutical products. This position also involves the development of production equipment service and maintenance procedures and manuals, which include calibration, preventative maintenance, troubleshooting and repair processes.
All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.
Duties and Responsibilities
- Draft production process documentation in the form of production operator work Instructions, batch production records and other production procedures.
- Participate in the equipment qualification process, analyzing the use and performance of production equipment and translating this information into associated documentation. This may include collaborating with engineers, and/or working with the equipment to verify operation.
- Assist with the development and implementation of NorthStar Medical Radioisotopes quality system processes and ensure compliance of applicable quality system regulations.
- Assist with creation and management of NorthStar’s Equipment files including generation of work instructions, validations, assessments and other documentation as needed.
Bachelor’s or Technical Degree in Engineering or Science and one to three years of experience in an FDA regulated environment; or equivalent combination of education and experience. Experience with authoring technical systems documentation, including manufacturing processes, within a medical device/pharmaceutical industry preferred.
Madison isn’t just the “Capital City,” it also houses NorthStar Medical Radioisotopes’ Research and Development facilities.
The Madison region is a place where dynamic, talented, innovative and hardworking people want to be. We know this because the region is growing at a faster rate than the state and the nation. Madison, Wis. was named first on Livability’s top 100 places to live in 2014.
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.
NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law.
Technical Writer – 3060 Progress Rd. Madison, WI 53511