Quality Control Specialist

Overview

Accelerate your career with NorthStar!

NorthStar Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner. We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services.

At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities.

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, paid parental leave 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 support to various quality aspects associated with the processing of radiopharmaceutical isotopes and radiologic science laboratories within the Quality Control team. The role will focus on support activities, such as sampling, general GMP laboratory testing/support, manufacturing operations, and batch release testing of radioactive products. This role requires extensive training on radiation safety including ALARA (“as low as reasonably achievable”) principles.

Projects and 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.

Responsibilities

• Operate analytical instrumentation.
• Author and revise documents in the eQMS system.
• Train others on methods, procedures and techniques as required.
• Safely handle radioactive material, which includes monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys.
• Perform and review receiving inspection tasks for release in the ERP system.
• Perform environmental monitoring in accordance with all applicable standards.
• Participate in DCO collaboration of documents in support of manufacturing and quality testing including test data, protocols, reports, SOPs.
• Perform technical review of analytical data and lab logbooks.
• Execute microbiological, chemical, radiochemical, and stability testing.
• Initiate and approve non-conforming material reports (NCMRs), investigate deviations, laboratory out-of-specification (OOS), and CAPA investigations.
• Participate in multiple Project Teams and other meetings.

After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories.
• Trained on ALARA principles and RAD safety.
• Be able to perform basic environmental monitoring and receiving inspection techniques.
• Provide support to site operational readiness.

After 6 months you will:

• Be qualified on more advanced analytical techniques such as HPLC.
• Support final product testing and batch processes.
• Be qualified to provide training to other team members on certain QC functions.

Qualifications

Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and minimum three (3) years of experience in a regulated industry; or equivalent combination of education and experience. Preferred qualification include:

• Four (4) years of related experience in a cGMP environment and previous experience handling radioactive materials.
• Understanding of pharmaceutical manufacturing processes, and familiarity with batch production records (BPR) preferred.
• Familiarity with alpha, gamma, and beta spectroscopy is a plus.

Working Conditions

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.

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.

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.