Kelly Science & Clinical has a direct hire opportunity for a Senior QA Specialist in Rochester, MN!

A Direct Hire Opportunity
Salary Range: $95,000-$110,000
M-F 8am-5pm

Overview:
Seeking an experienced Senior QA Specialist to maintain and improve quality systems in a pharmaceutical/biotech environment. This role oversees Management Review & Risk Management, Change Control Management, and Quality Metrics & Monitoring, collaborating across departments to ensure regulatory compliance and continuous improvement.

Key Responsibilities:

• Facilitate management review meetings and risk assessments
  

• Lead development of risk management frameworks and communicate findings
  

• Oversee end-to-end change control processes and documentation per FDA and ICH regulations
  

• Collaborate with cross-functional teams on change implementation
  

• Define, analyze, and report quality metrics (KPIs, CAPA, audit findings)
  

• Develop quality dashboards, identify trends, and recommend corrective actions
  

• Train staff on quality procedures and maintain SOPs

Qualifications:

• Bachelor’s in Life Sciences or related field (Master’s and ASQ CQA preferred)
  

• 5+ years QA experience in a GMP-regulated pharmaceutical/biotech setting
  

• Strong knowledge of quality systems, FDA/ICH regulations, and eQMS platforms
  

• Skilled in data analysis and reporting tools (e.g., Excel, Power BI)
  

• Excellent communication, organizational, and project management abilities

Compensation and benefits:
Salary is commensurate with experience and qualifications. A comprehensive benefits package including:

• Paid Holidays
  

• PTO
  

• Health insurance
  

• Dental/vision insurance
  

• Life insurance
  

• Employer paid short- and long-term disability
  

• AD&D
  

• Simple IRA with an employer match
  

• Annual bonus

Salary will range between $95k-$110k based on education, title, and related experience. If you, or someone you know, would like to be considered please apply online today to discuss the next steps!
 

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