QA Specialist

By | April 17, 2026

QA Specialist

Apply Now Applied

Job ID: 10192431

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Rochester, MN, US

Scientific

Bachelors Degree

Full Time, Direct Hire

$75,000-$95,000

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Rochester, MN, US

$75,000-$95,000

Experienced (Non-Manager)

Full Time, Direct Hire

Biotechnology/Pharmaceuticals

On-site

Scientific

Bachelors Degree

First Shift (Day)

Apply Now Applied

Job details

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!
 

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