Job Description

Join the team as a Quality Control Specialist at NorthStar Medical Radioisotopes in Beloit, WI.

As a Quality Control Specialist, you will support various quality functions related to radiopharmaceutical isotope processing and laboratory operations. This includes sampling, GMP lab testing, manufacturing support, and batch release testing of radioactive products. You’ll play a critical role in ensuring compliance with all applicable regulatory requirements while upholding the highest standards of safety and quality in a highly specialized, collaborative environment.

NorthStar Medical Radioisotopes seeks individuals who 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.

Benefits

• Access to innovative technology
• Opportunities for career advancement
• Competitive compensation
• Health and life insurance
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• Eligibility on day one for annual bonus and equity incentive plans

Shift Information

• This position supports a 24-hour manufacturing facility; schedule includes weekday time off when weekend work is required
• Early morning, late evening, weekend, and some holiday work will be required
• Occasional overtime may be necessary

Required Education and Experience

• Bachelor’s Degree in Chemistry, Biology, or a related scientific discipline AND
• 3+ years of experience in a regulated industry, OR
• Equivalent combination of education and experience

Preferred Experience

• 4+ years in a cGMP environment
• Experience handling radioactive materials
• Familiarity with pharmaceutical manufacturing processes and batch production records
• Experience with alpha, gamma, or beta spectroscopy

Essential Functions

• Operate analytical instrumentation
• Author and revise documents within the eQMS system
• Train team members on methods, procedures, and techniques as required
• Safely handle radioactive materials, including dose monitoring, sampling, aliquoting, and contamination surveys
• Perform and review receiving inspection tasks for material release in the ERP system
• Conduct environmental monitoring in accordance with applicable standards
• Collaborate on DCOs related to manufacturing and quality testing documents, including test data, protocols, reports, and SOPs
• Review analytical data and laboratory logbooks for technical accuracy
• Perform microbiological, chemical, radiochemical, and stability testing
• Initiate and approve non-conforming material reports (NCMRs); investigate deviations, laboratory out-of-specification (OOS) results, and CAPA events
• Participate in project teams and other assigned meetings

Working Conditions

• Work takes place in indoor office, cleanroom, and manufacturing environments with exposure to varying temperatures and noise levels
• PPE is mandatory, including respirators, gloves, safety glasses, and full-body protection
• Employees must comply with cleanroom policies, including restrictions on jewelry, cosmetics, nail products, and fragranced items
• Work may involve radiation exposure; dosimetry and bioassay testing are required

Physical Demands

• Specific vision abilities required, including near vision/acuity and color discrimination
• Must be able to perform tasks requiring manual dexterity and attention to detail

General Requirements

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 must 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.

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