["Quality Assurance Specialist (2nd Shift)","Quality Assurance Specialist (2nd Shift)"]

Overview Join the best radiopharmaceutical company in the world!If you're looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer.At the forefront of NorthStar's technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission - advancing life‑saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world‑class facilities and a competitive benefits package.Responsibilities Effectively communicate safety and quality issues raised by customers or staff in a timely manner.Quality Assurance Responsibilities Review and approve production records (electronic and paper) to ensure accuracy, completeness, and compliance with GMP requirementsReview and approve documentation supporting manufacturing and quality system processes, including batch records, test data, and supporting recordsApprove Certificate of Analysis (CoA) activities for final product release and shipmentReview and approve environmental monitoring (EM) data, media fills, gowning qualifications, and calibration certificationsQuality Systems & Documentation Review, collaborate on, and approve controlled documents, including document change orders (DCOs) and change requests for released processesAuthor, revise, distribute, and reconcile controlled documents within the eQMSSupport development and continuous improvement of quality system processesInvestigations & Compliance Initiate, investigate, and approve nonconformances, deviations, and laboratory out-of-specification (OOS) resultsPerform risk assessments and lead root cause analyses to support corrective and preventive actionsParticipate in internal, sponsor, and regulatory audits; lead internal audits as assignedTrain team members on job functions and quality system requirementsDevelop and deliver companywide training on eQMS processesCreate, track, and report departmental quality metricsServe as a subject matter expert (SME) to support continuous improvement initiatives and new process implementationQualifications Bachelor's Degree in Chemistry, Biology, or other related scientific discipline and minimum three (3) years GMP related experience in biopharmaceutical/pharmaceutical or other regulated industry with direct Quality experience; or equivalent combination of education and experience.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. Under federal law, only truthful information may be provided on the Form I-9.#J-18808-Ljbffr