Quality Control Specialist (1st shift

North Star Medical Radioisotopes 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.

Responsibilities include operating analytical instrumentation, authoring and revising documents in the eQMS system, training others on methods, procedures and techniques as required, safely handling radioactive material, performing and reviewing receiving inspection tasks for release in the ERP system, performing environmental monitoring in accordance with all applicable standards, participating in DCO collaboration of documents in support of manufacturing and quality testing including test data, protocols, reports, SOPs, performing technical review of analytical data and lab logbooks, executing microbiological, chemical, radiochemical, and stability testing, initiating and approving non-conforming material reports (NCMRs), investigating deviations, laboratory out-of-specification (OOS), and CAPA investigations, participating in multiple Project Teams and other meetings.

After three months you will be qualified to enter controlled spaces such as laboratories, trained on ALARA principles and RAD safety, able to perform basic environmental monitoring and receiving inspection techniques, and provide support to site operational readiness. After six months you will be qualified on more advanced analytical techniques such as HPLC, support final product testing and batch processes, and be qualified to provide training to other team members on certain QC functions.

Bachelor's Degree in Chemistry, Biology, or other related scientific discipline and minimum three (3) years of experience in a regulated industry (e.g., analytical instrumentation / prior laboratory experience); 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.

1st Shift: 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.

Benefits include medical, dental, and vision insurance, Healthcare Flex Spending Account (FSA) and Dependent Care FSA, company-paid short-term and long-term disability, company-paid life insurance & AD&D coverage, pet insurance, 401(k) match, paid holidays and paid time off (PTO), paid parental leave, bonus plan, and Equity Incentive Program.

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination. This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors, noise levels range from quiet to loud, depending on the work area, specific vision abilities, including near vision, visual acuity, and color discrimination.

Personal Protective Equipment (PPE) is required and may include respirators, gloves, safety glasses, and full protective clothing. Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings) is required. Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions is required. As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas.

Employees in this role may be required to follow strict radiation safety procedures, participate in dosimetry monitoring and bioassay testing as part of the company protocol, and inform leadership of any health conditions that may affect product integrity, by…