Total Quality Senior Specialist jobs in Janesville, WI

Overview

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.

Position

The primary role of this position is to provide support to and lead 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.     

Duties will be completed in compliance with applicable cGMP, cGLP, FDA, and all other 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, weekend, and some holiday work will be required with occasional overtime.

Responsibilities

• 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.
• Perform QC functions for ISO 7 and ISO 8 cleanroom cGMP manufacturing operations.
• Initiate and approve non-conforming materials reports (NCMRs), investigate deviations, laboratory out-of-specification (OOS), and CAPA investigations. Perform risk assessments, participate in root cause analysis investigations, tracking, follow-up, and reporting/trending.
• 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.
• Serve as the subject matter expert in analytical instrumentation.

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. 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.

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.

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.