Senior QA Lead & Compliance Auditor

BIO-TECHNE Corp; Newark (CA); Presencial; USD 89.000 - 147.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401k plan

Employee stock purchase plan (ESPP)

Tuition reimbursement

Descripción de la vacante

Bio-Techne seeks a seasoned Quality Assurance Specialist to ensure compliance with ISO 13485 and FDA Quality System Requirements. The role emphasizes document control, internal audits, CAPA management, and regulatory readiness.

The ideal candidate has a BS in a related field and 8+ years in QA, with ASQ CQE/CQA or Lead Auditor certifications preferred. Onsite work in a lab/production environment with strong Excel data skills is expected.

Formación

• B.S. or B.A. in a related science, engineering, or related field preferred.
• 8+ years of QA experience in a QA function for senior role.
• ASQ CQE, CQA, or Lead Auditor certifications preferred.

Responsabilidades

• Document Control activities using an electronic database.
• Conduct internal audits on a periodic basis per plan.
• Prepare written audit reports and report findings.
• Prepare quality records for regulatory inspections.
• Assist with batch record review and release or hold.
• Review nonconformances and CAPAs; host CAPA/Materials Review Board meetings.
• Maintain QA indicators and assist Management Review data prep.
• Write validation plans/reports and execute validations.
• Write/revise QA SOPs and perform other QA duties as required.

Conocimientos

Quality Assurance

QA regulations

Lead Auditor

CAPA processes

Data analysis (Excel)

Documentation control

Educación

Bachelor's degree in a related science/engineering

Herramientas

Electronic Database

Descripción del empleo

Bio-Techne seeks a seasoned Quality Assurance Specialist to ensure compliance with ISO 13485 and FDA Quality System Requirements. The role emphasizes document control, internal audits, CAPA management, and regulatory readiness.

The ideal candidate has a BS in a related field and 8+ years in QA, with ASQ CQE/CQA or Lead Auditor certifications preferred. Onsite work in a lab/production environment with strong Excel data skills is expected.