GMP Quality Assurance & Compliance Specialist

NorthStar Medical Technologies; Beloit (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

NorthStar Medical Radioisotopes in Beloit, WI seeks a Quality Assurance professional to lead GMP-compliant QA activities, review production records, and approve CoAs for final product release. The role requires deep experience with eQMS, deviation handling, audits, and training across the quality system.

The ideal candidate has a Bachelor’s in chemistry or biology and at least three years of GMP-related quality experience in a regulated setting, with strong documentation skills and a proactive

Qualifications

• Bachelor’s degree in chemistry, biology, or related field with GMP experience.
• Minimum three years of GMP-related quality experience in biopharma/pharma or regulated industry.
• Strong understanding of QA processes and documentation controls.

Responsibilities

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• Review and approve production records to ensure GMP compliance.
• Review and approve documentation supporting manufacturing and quality system processes.
• Approve CoA activities for final product release and shipment.
• Review environmental monitoring data, media fills, gowning qualifications, and calibration certifications.
• Review, collaborate on, and approve controlled documents and change orders.
• Author, revise, and distribute controlled documents within the eQMS.
• Support development and continuous improvement of quality system processes.
• Initiate, investigate, and approve nonconformances and CAPAs; lead root cause analyses.
• Participate in internal, sponsor, and regulatory audits; lead internal audits as assigned.
• Train team members on job functions and quality system requirements.
• Develop and deliver company-wide training on eQMS processes.
• Create, track, and report departmental quality metrics.
• Serve as SME to support continuous improvement initiatives and new process implementation.

Skills

Quality Assurance

GMP Compliance

Documentation Management

Auditing

Training

Education

Bachelor’s Degree in Chemistry or Biology

Tools

eQMS

CoA Documentation

Job description

NorthStar Medical Radioisotopes in Beloit, WI seeks a Quality Assurance professional to lead GMP-compliant QA activities, review production records, and approve CoAs for final product release. The role requires deep experience with eQMS, deviation handling, audits, and training across the quality system.

The ideal candidate has a Bachelor’s in chemistry or biology and at least three years of GMP-related quality experience in a regulated setting, with strong documentation skills and a proactive