Quality Control Lead

NorthStar Medical Radioisotopes•Beloit, WI

7d•Onsite

About The Position

The Quality Control Lead conducts and validates biological and analytical quality control assays associated with processing radiopharmaceutical isotopes and drugs, ensuring compliance with established standards and applicable regulatory requirements. The role requires extensive radiation safety training, including ALARA principles, and supports production at a 24-hour manufacturing facility. The position leads and coordinates QC team activities, provides training, operates and troubleshoots analytical instruments, and serves as a subject matter expert in analytical instrumentation. It authors, reviews, and approves quality documentation and supports method validation transfers, investigations, audits, and multiple projects. The role also supports the department manager or designee in their absence. During the first three months, the employee is expected to qualify for controlled laboratory spaces, complete ALARA and radiation safety training, support operational readiness, and begin training in final product testing and batch processes. By six months, the employee is expected to qualify in advanced techniques such as HPLC, become proficient in most QC batch release activities, support tech transfer, stability, and product validation testing, and qualify to train other team members on certain QC functions. The job is based at NorthStar Medical Radioisotopes’ facility in Beloit, Wisconsin. It may involve controlled cleanroom, office, and manufacturing environments, with potential radiation exposure and required use of personal protective equipment. The schedule includes early mornings, late evenings, weekends, some holidays, and occasional overtime; days off may fall during the week when weekend work is required.

Requirements

Bachelor’s degree in Chemistry, Biology, or another related scientific discipline and at least nine years of experience in a regulated industry, or an equivalent combination of education and experience.
Ability to complete required radiation safety training and follow ALARA principles.
Ability to work early mornings, late evenings, weekends, and some holidays, with occasional overtime.
Ability to follow radiation safety procedures and participate in dosimetry monitoring and bioassay testing as required.
Ability to comply with cleanroom gowning protocols and personal protective equipment requirements.

Nice To Haves

Nine years of related experience in a cGMP environment.
Previous experience handling radioactive materials.
Understanding of pharmaceutical manufacturing processes.
Familiarity with alpha, gamma, and beta spectroscopy.

Responsibilities

Communicate safety and quality issues raised by customers or staff in a timely manner.
Lead, coordinate, and communicate QC team responsibilities and activities.
Provide on-the-job training for the QC team and assist in troubleshooting analytical instruments.
Operate analytical instrumentation proficiently.
Conduct company-wide training and facilitate a training program for QC personnel on industry best practices for ISO-controlled environments.
Author, review, and approve quality test data, protocols, reports, and SOPs.
Assist with transferring validation activities for QC test methods.
Serve as the subject matter expert in analytical instrumentation.
Independently lead multiple projects and meetings.
Support the department manager and/or designee in their absence.
Initiate and approve non-conforming materials reports (NCMRs); investigate deviations, laboratory out-of-specification (OOS) results, and CAPA investigations.
Perform risk assessments and participate in root cause analysis investigations, tracking, follow-up, and reporting or trending.
Participate in internal assessments and regulatory audits as required.
Support site operational readiness and train on final product testing and batch processes.
Support tech transfer, stability, and product validation testing.