Quality Assurance Specialist

NorthStar Medical Radioisotopes•Beloit, WI

8d•Onsite

About The Position

The Quality Assurance Specialist supports manufacturing and quality operations by maintaining quality systems and ensuring compliance with GMP, GLP, safety, and regulatory requirements. The role provides on-the-floor QA oversight, supports quality issue remediation, and collaborates with cross-functional teams to uphold quality standards. All work is performed in accordance with company policies, procedures, global regulations, and safety requirements. The position supports production at a 24-hour manufacturing facility and requires early morning, weekend, and some holiday work. Work may take place in controlled cleanrooms, office settings, or manufacturing areas. The role may involve temperature variation, differing noise levels, radiation safety procedures, and use of required personal protective equipment. Radiation dosimetry monitoring and bioassay testing may be required. The position is based at NorthStar Medical Radioisotopes’ headquarters and primary manufacturing facility in Beloit, Wisconsin, and is eligible for a lump-sum relocation benefit.

Requirements

Bachelor’s degree in Chemistry, Biology, or another related scientific discipline, and at least three years of GMP-related experience in a biopharmaceutical, pharmaceutical, or other regulated industry with direct Quality experience; or an equivalent combination of education and experience.
Follow strict radiation safety procedures and participate in dosimetry monitoring and bioassay testing as required by company protocol.
Comply with cleanroom gowning requirements, including restrictions on jewelry, cosmetics, fragrances, and nail products.
Use required personal protective equipment, which may include respirators, gloves, safety glasses, and full protective clothing.
Inform leadership of health conditions that may affect product integrity under cleanroom standards.
Complete Form I-9 verification of identity and employment authorization on or before the first day of employment; the company cannot provide immigration-related sponsorship.

Responsibilities

Communicate safety and quality issues raised by customers or staff in a timely manner.
Review and approve electronic and paper production records for accuracy, completeness, and GMP compliance.
Review and approve documentation supporting manufacturing and quality system processes, including batch records, test data, and supporting records.
Approve Certificate of Analysis activities for final product release and shipment.
Review and approve environmental monitoring data, media fills, gowning qualifications, and calibration certifications.
Review, collaborate on, and approve controlled documents, including document change orders and change requests for released processes.
Author, revise, distribute, and reconcile controlled documents in the eQMS.
Support development and continuous improvement of quality system processes.
Initiate, investigate, and approve nonconformances, deviations, and laboratory out-of-specification results.
Perform risk assessments and lead root cause analyses to support corrective and preventive actions.
Participate in internal, sponsor, and regulatory audits, and lead internal audits as assigned.
Train team members on job functions and quality system requirements.
Develop and deliver companywide training on eQMS processes.
Create, track, and report departmental quality metrics.
Serve as a subject matter expert to support continuous improvement initiatives and new process implementation.
Complete radiation training for building access.
Review and approve documentation for closure independently and perform QA support functions during operations with a QA trainer during the initial development period.
Collaborate on and approve applicable document change orders, perform final batch production record review and Certificate of Analysis completion for release and shipment, review and investigate events, and review change requests for completeness as proficiency develops.
Collaborate with cross-functional departments, provide guidance and continuous improvement, and work independently while making decisions during production activities.