QA Specialist-Laboratory Quality & Data Integrity

QA Specialist – Laboratory Quality & Data Integrity

Company: Pharmaceutical/Biotechnology

Location: Rochester, MN

Employment Type: Full-Time | Direct Hire

Compensation: $75,000 – $95,000 (Commensurate with experience)

About the Role

We are seeking a detail-oriented QA Specialist – Laboratory Quality & Data Integrity to support our laboratory programs within a Biotech/CRO environment. This role ensures our lab operations meet rigorous regulatory standards through data integrity oversight, method validation, and sample management. The ideal candidate has hands-on experience in GCLP or GLP-regulated settings.

Key Responsibilities

Data Integrity & GDP Quality Control

• Subject Matter Expert: Serve as the SME for Data Integrity and Good Documentation Practices (GDP) across lab operations.
• Audits & Assessments: Conduct audits and gap assessments against FDA 21 CFR Part 11 and ALCOA principles.
• Compliance Documentation: Develop and maintain SOPs for GDP and data integrity controls.
• Investigations: Lead investigations into data integrity deviations and drive corrective/preventive actions (CAPAs).

Assay Qualification & Validation

• QA Oversight: Review and approve validation studies (accuracy, precision, specificity, etc.) in alignment with ICH Q2(R1).
• Scientific Collaboration: Partner with laboratory scientists to ensure study designs comply with GxP requirements.
• Master Planning: Maintain assay validation master plans and associated technical documentation.

Method Transfer & Project Management

• Technical Transfers: Support analytical method transfers between internal departments or external partners, ensuring scientific rigor.
• Project Liaison: Act as the QA lead on cross-functional teams, providing quality guidance throughout the project lifecycle.
• Audit Support: Assist with client audits, sponsor audits, and regulatory inspections.

Laboratory Management Support

• Equipment Qualification: Assist in the qualification of lab instruments (IQ/OQ/PQ).
• Monitoring: Monitor laboratory quality indicators and contribute to periodic quality review meetings.
• Change Control: Review and approve changes affecting lab methods, equipment, or procedures.

Qualifications

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or Biology (Required); Master’s degree (Preferred).
• Experience: Minimum 5 years of QA experience in a regulated laboratory environment (Required).
• Industry Focus: Direct experience in a GCLP or GLP-regulated biotech or CRO setting (Strongly Preferred).
• Technical Proficiency: Demonstrated experience in at least three areas: data integrity, assay validation, sample management, method transfer, or lab QA.
• Regulatory Knowledge: Deep understanding of ALCOA , 21 CFR Part 11, ICH Q2(R1), and FDA Bioanalytical Method Validation (BMV) guidance.
• Systems: Experience with LIMS, Electronic Lab Notebooks (ELN), and eQMS platforms (e.g., Qualio).

Benefits & Compensation

• Financial: Simple IRA with employer match, Annual Bonus, and Life Insurance.
• Health: Comprehensive Medical, Dental, and Vision insurance.
• Disability: Employer-paid Short-Term and Long-Term Disability AD&D.
• Balance: Paid Holidays and a generous PTO policy.