Job Description

Join the team as a Radiopharmaceutical Manufacturing Specialist at NorthStar Medical Radioisotopes in Beloit, WI. As a Radiopharmaceutical Manufacturing Specialist, you will prepare equipment, dissolve products, and dispense medical radioisotopes while strictly adhering to established procedures, instructions, and regulatory requirements. Your role will ensure full compliance with all applicable industry standards and guidelines, maintaining the highest levels of safety, precision, and quality in radiopharmaceutical production.

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 Package

• Pay of $29/hour
• Health and life insurance
• 401K match
• Paid holidays and paid time off
• Paid parental leave
• Eligible for an annual target bonus opportunity
• Opportunity for advancement

Shift Information

• This position supports production in a 24-hour manufacturing facility, so 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.
• Requirements for this position include the ability to work 1st, 2nd, and 3rd shifts during the training period (several months). Then transition to a 2nd or 3rd shift

Education and Experience

• Associate’s Degree (AS) OR Bachelor’s Degree (BS) in a STEM discipline AND
• 2+ years of cGMP experience OR
• An equivalent combination of education and experience. Relevant military experience will also be considered.
• Experience working with Contract Development and Manufacturing Organizations (CDMOs) or Contract Manufacturing Organizations (CMOs)
• A strong background in chemistry and expertise in aseptic processes , including cleanroom environments and equipment qualification

Essential Functions

• Execute radiopharmaceutical manufacturing processes, including equipment preparation, dissolution, and dispensing of medical radioisotopes.
• Ensure compliance with cGMP standards, following all applicable procedures and guidelines.
• Assist in preparing and maintaining manufacturing records such as Batch Records, Forms, and Logbooks.
• Review production work orders and ensure schedule adherence.
• Author, review, and update cGMP documentation, including Batch Production Records (BPR) and Standard Operating Procedures (SOP), works Instructions (WI), and Production Checklists while upholding NorthStar’s QMS guidelines.
• Conduct safety checks and inspections of production equipment and cleanrooms.
• Maintain accurate inventory of materials and consumables.
• Ensure cleanroom and manufacturing areas remain organized and compliant with policies and procedures.
• Troubleshoot production issues and collaborate with cross-functional teams to implement improvements.
• Participate in production scale-up and continuous process improvement initiatives.
• Employ root cause analysis and investigation methodologies to drive process enhancements.

Working Conditions

• Exposure to indoor office, manufacturing, and cleanroom environments with temperature-controlled conditions
• Potential outdoor work in varying temperatures
• Noise levels range from quiet to loud
• PPE is required, including respirators, gloves, safety glasses, and protective clothing
• Compliance with cleanroom protocols, including restrictions on jewelry, cosmetics, and fragranced products

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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