Quality Control Specialist at NorthStar Medical Technologies

Beloit, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jan, 26

Salary

0.0

Posted On

06 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Instrumentation, GMP Laboratory Testing, Radiation Safety, Environmental Monitoring, Microbiological Testing, Chemical Testing, Radiochemical Testing, Stability Testing, Document Control, Non-Conforming Material Reports, Batch Release Testing, Training, Quality Control, Pharmaceutical Manufacturing, Spectroscopy

Industry

Pharmaceutical Manufacturing

Description

Overview Join the best radiopharmaceutical company in the world! If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. 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. At the forefront of NorthStar’s technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission—advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package. 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 qualifications 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. 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. 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.

Responsibilities

The Quality Control Specialist will support various quality aspects associated with the processing of radiopharmaceutical isotopes and radiologic science laboratories. Responsibilities include operating analytical instrumentation, performing laboratory testing, and ensuring compliance with regulatory standards.