Quality Assurance Senior Specialist

The Quality Assurance (QA) Senior Specialist will provide lead oversight to ensure our quality systems are robust, compliant with regulatory standards, and continuous improvement. The QA Senior Specialist will be responsible for developing and revising site procedures, leading investigations, and corrective actions, participating in regulatory inspections, coordinating quality metrics, and ensuring the highest standards of product quality across the manufacturing process.

Description

PRINCIPAL RESPONSIBILITIES:

• Documentation & Compliance: Support creation, review, and updates of procedures, work instructions, and training materials to meet GMP and regulatory standards.
• Investigations & CAPA: Oversee and approve quality investigations, CAPAs, and change controls. Collaborate cross-functionally to resolve issues and prevent recurrence.
• Regulatory Inspections: Represent QA during audits and inspections (e.g., FDA), ensuring compliance and timely resolution of findings.
• Complaints & Quality Events: Lead investigations into customer complaints and quality events, ensuring timely root cause analysis and corrective actions.
• QA Metrics: Track and analyze QA performance metrics to drive improvements and ensure system effectiveness.
• Batch Review & Product Release: Review batch records for accuracy and completeness and make final disposition decisions.
• Audits: Conduct internal audits and participate in third-party inspections to ensure ongoing compliance.
• Risk Management: Participate in risk assessments and help implement mitigation strategies.
• Material & Supplier Oversight: Evaluate and approve incoming materials and components, and support supplier qualification processes.
• Manufacturing Support: Maintain QA presence on the manufacturing floor, ensure equipment compliance, and review records for CGMP adherence.
• Training & Documentation Control: Deliver GMP training and assist with document control systems.
• Continuous Improvement: Lead initiatives to optimize quality processes and increase operational efficiency.
• Safety & Compliance: Promote a culture of safety and compliance throughout the organization.
• Perform other duties as assigned.
  
  

Qualifications & Experience

• Bachelor’s degree in a related field (e.g., Biology, Microbiology or Chemistry) or equivalent experience in Quality Assurance required.
• Minimum of 3 years of experience in Quality Assurance within a sterile pharmaceutical, biotech, or related manufacturing industry required.
• Minimum 2 Experience leading investigations, CAPAs, and audits within an FDA GMP-compliant environment required.
• Minimum 2 Experience of on the floor support for manufacturing operations required.
• In-depth knowledge of GMP, FDA regulations, and industry best practices, specifically 21 CFR 210, 211 in the FDA.
• Strong written and verbal communication skills, with the ability to collaborate effectively across teams.
• Demonstrated problem-solving skills with the ability to analyze complex issues and implement effective solutions.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
• Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Engineering, Operations, Research and Development teams.
• Working knowledge of Microsoft Office Suite specifically Microsoft Word and Excel strongly preferred.
• Working knowledge of Adobe editing software strongly preferred.
• Working knowledge of working in hybrid QMS system (paper/electronic).
• Ability to work in a cleanroom and sterile compounding environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.
• Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
• Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.
• Proper garbing and personal hygiene must be maintained at all times when in the cleanroom or compounding areas.
  
  

The Fine Print

The salary range in Minnesota is $80,000 to $100,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location.

Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in

compliance with applicable law.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied

contract of employment; employment remains “at-will”.

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.