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

A Direct Hire Opportunity
Salary Range: $75,000-$95,000
M-F 8am-5pm

Summary:
Seeking a detail-oriented QA Specialist to strengthen laboratory quality and data integrity programs in a biotech/CRO environment. Responsible for ensuring regulatory compliance, robust data practices, method validation oversight, and cross-functional project support.
Key Responsibilities:

• Serve as SME for data integrity and Good Documentation Practices, conducting audits and training staff
  

• Oversee and review assay qualification/validation studies and documentation
  

• Support analytical method transfers, review protocols, and ensure scientific rigor
  

• Act as QA liaison on project teams and manage QA deliverables and timelines
  

• Participate in lab management activities including audits, deviation investigations, and equipment qualification
  

• Maintain and improve SOPs, quality indicators, and inspection readiness

Qualifications:

• Bachelor’s degree in Life Sciences or related field (Master’s preferred)
  

• 3-5 years of QA experience in a regulated laboratory setting
  

• Hands-on experience in GCLP or GLP-regulated biotech/CRO environment
  

• Expertise in at least three: data integrity, assay validation, sample management, method transfer, or lab QA
  

• Knowledge of ALCOA , FDA 21 CFR Part 11, ICH Q2(R1), and related regulations
  

• Experience with LIMS/ELN; proficiency with Microsoft Office and eQMS platforms

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 $75k-$95k 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!

10192431

Seeking a detail-oriented QA Specialist to strengthen laboratory quality and data integrity programs in a biotech/ CRO environment. Responsible for ensuring regulatory compliance, robust data practices, method validation oversight, and cross-functional project support. Key Responsibilities: Serve as SME for data integrity and Good Documentation Practices, conducting audits and training staff Oversee and review assay qualification/validation studies and documentation Support analytical method transfers, review protocols, and ensure scientific rigor Act as QA liaison on project teams and manage QA deliverables and timelines Participate in lab management activities including audits, deviation investigations, and equipment qualification Maintain and improve SOPs, quality indicators, and inspection readiness Qualifications: Bachelor’s degree in Life Sciences or related field (Master’s preferred) 3-5 years of QA experience in a regulated laboratory setting Hands-on experience in GCLP or GLP-regulated biotech/ CRO environment Expertise in at least three: data integrity, assay validation, sample management, method transfer, or lab QA Knowledge of ALCOA , FDA 21 CFR Part 11, ICH Q 2(R 1), and related regulations Experience with LIMS/ ELN; proficiency with Microsoft Office and e. QMS platforms 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 $75 k-$95 k 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! 10192431

search terms: QA+Specialist