Quality Control Specialist

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.

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.

Position

The primary role of this position is to provide operational support for the Quality Control (QC) cGMP functions for laboratory, radiologic science laboratory, and manufacturing operations.  The role will focus on support activities, such as sampling, material inspection, and general laboratory testing/support.

Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies’ standards.

Duties and Responsibilities

• Monitor equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
• Operate analytical instrumentation (i.e. HPLC, Bacterial Endosafe, pH meter). This may also include dose calibrators, survey meters, dosimetry monitors, and wipe test counters.
• Participate in authoring and/or revision of Standard Operating Procedures (SOPs) and forms.
• Provide on-the-floor QC oversight of manufacturing operations.
• Perform incoming inspection of raw materials and components.

Qualifications

Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and two to four years of related experience in a cGMP environment; or equivalent combination of education and experience.  Experience with executing QC test methods (preferably endotoxin, bioburden, sterility, environmental monitoring, pH, chemical ID testing), generating associated data packages, reviewing/auditing data packages generated by others, trending data, and statistical analyses required.  Familiarity with use of basic to advanced metrological equipment preferred. Knowledge of ALARA principles, operating radiation detection equipment, and handling of radioactive materials preferred.  Understanding of pharmaceutical manufacturing processes, 21CFR210/211/820/11 ideal.

Location

NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.

Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.

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.

Quality Control Specialist – 1800 Gateway Blvd. Beloit, WI 53511