Radiopharmaceutical Manufacturing Specialist (1st shift)

Execute various aspects of radiopharmaceutical manufacturing

• Pre-production set-up
• Manufacturing processes
• Post-production activities
• Waste stream management

Audit and Documentation

• Accurate and timely preparation and completion of records manufacturing, including Batch Records, Forms, Logbooks, etc.
• Review production Work Orders on the production schedule.
• Author, review, and revise cGMP documentations, such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Works Instructions (WI), and Production Checklists while upholding NorthStar’s QMS guidelines.

Safety and Compliance

• Perform safety checks and routine inspection of the production processing equipment and control systems, consumables, and cleanrooms to ensure compliant manufacturing.
• Notify leader of equipment or operating problems and the need for additional materials, supplies, or investigations.

Inventory Management and Cleanroom Maintenance

• Maintain accurate inventory of materials and consumables, and coordinate equipment traceability under the direction of the leader.
• Contribute to interdepartmental projects including production scale-up and continuous process improvement.

Associate’s Degree (AS) in a STEM discipline and minimum two (2) years of cGMP (pharmaceutical or medical device), ISO 15189 (hospital), CLIA (clinical laboratory), ISO 9001 (industrial manufacturing), IATF 16949 (automotive) or AS9100 (aerospace) experience; or equivalent combination of education and experience.

Résumés are due by [Insert Deadline Date]. 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.