Radiopharmaceutical Production & QA Specialist

NorthStar Medical Technologies; Beloit (WI); On-site; USD 45,000 - 75,000; Full time

Job summary

NorthStar Medical Radioisotopes in Beloit, WI is seeking a manufacturing professional to join our radiopharmaceutical production team. You will help with pre-production setup, manufacturing processes, post-production activities, and waste stream management.

The role requires at least an Associate's or Bachelor's in STEM and at least two years of cGMP/ISO-related experience; CDMO/CMO and aseptic processing knowledge preferred.

Qualifications

• Two years of cGMP experience (pharmaceutical or medical device).
• Knowledge of various quality systems and document control is a plus.
• CDMO/CMO experience, aseptic processing knowledge preferred.

Responsibilities

• Execute various aspects of radiopharmaceutical manufacturing, including pre-production set-up, manufacturing processes, post-production activities, and waste stream management.
• Assist in accurate and timely preparation 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.
• 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.
• Maintain accurate inventory of materials and consumables, and coordinate equipment traceability under the direction of the leader.
• Perform and assist in maintaining the cleanliness and orderliness of the cleanroom and/or manufacturing spaces, equipment, and materials in accordance with NorthStar’s respective policies and procedures.
• Work cross‑functionally on employing standardized root cause analysis, investigation tools and methodologies.
• Contribute to interdepartmental projects including production scale‑up and continuous process improvement.

Education

Associate’s Degree (AS) in a STEM discipline

Bachelor’s Degree (BS) in a STEM discipline

Job description

NorthStar Medical Radioisotopes in Beloit, WI is seeking a manufacturing professional to join our radiopharmaceutical production team. You will help with pre-production setup, manufacturing processes, post-production activities, and waste stream management.

The role requires at least an Associate's or Bachelor's in STEM and at least two years of cGMP/ISO-related experience; CDMO/CMO and aseptic processing knowledge preferred.