Quality Control Analyst/Senior Quality Control Analyst - NorthStar Medical Radioisotopes

Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team.

NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer, and customized radiopharmaceutical development services.

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 primary role of this position is to conduct and validate various biological and analytical quality control assays associated with the processing of radiopharmaceutical isotopes and drugs to ensure compliance with established standards.   This role requires extensive training on radiation safety including ALARA (“as low as reasonably achievable”) principles.  

The Senior Quality Control Analyst will lead various activities, as further described below.  

Duties will be completed in compliance with applicable regulatory agency standards.

This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required.  Early morning, late evening, weekend, and some holiday work will be required with occasional overtime.

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.

The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures.  The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions.  Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols.  This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment.  In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders. 

The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.

• Proficiently operate analytical instrumentation (i.e. scintillation counters, HPGe, ICP-MS, IC). 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 in the eQMS system.
• Perform incoming inspections of raw materials and components and release in the ERP system.
• Handle radioactive material, which includes monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys.
• Perform QC functions for ISO 7 and ISO 8 cleanroom cGMP manufacturing operations.
• Train to use manipulators for remote handling of high activity isotopes and radiopharmaceuticals inside hot cells.
• Execute microbiological, chemical, radiochemical, and stability testing.
• Lead and facilitate trouble shooting and root cause analysis for investigations for nonconformances

The Senior Quality Control Analyst will have additional responsibilities, including:

• Assist with the leadership and facilitation of trouble shooting and problem solving in order to learn possible solutions to problems and issues that may arise.
• Develop and validate Quality Control (QC) Radiochemistry test methods.
• Participate in internal assessments and regulatory audits as the SME, as required.
• Monitor equipment and instrumentation (HPGe, ICP-MS, HPLC, IC, dose calibrator, LSC) to ensure proper operation and calibration
• Mentor and train other members of QC, including new hires, to perform QC testing and procedures.
• Maintain QC Lab: Managing inventory and review of logbooks etc.
• Coordinate testing and EM schedule to ensure Production support.

Understanding of pharmaceutical manufacturing processes, 21 CFR 210/211/820 and familiarity with batch production records (BPR) preferred. Familiarity with alpha, gamma, and beta spectroscopy is a plus.

Quality Control Analyst Qualifications

Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline; or equivalent combination of education and experience.   Minimum one (1) year of related experience in a cGMP environment and previous experience handling radioactive materials preferred.

Senior Quality Control Analyst Qualifications

Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and a minimum of one (1) year related industry experience; or equivalent combination of education and experience.  Minimum three (3) years of related experience in a cGMP environment and previous experience handling radioactive materials preferred.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.  Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment.  Under federal law, only truthful information may be provided on the Form I-9.

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.

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.