Senior QA Specialist: Commissioning & Equipment Validation

QRC

Juncos (PR)

On-site

USD 110,000 - 150,000

Full time

3 days ago
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Job summary

QRC Group, LLC seeks a Sr. Specialist QA with proven expertise in commissioning and qualification, equipment validation, QRAES, Kneat, GDP, change controls, and SOPs.

The role requires bilingual English/Spanish communication and advanced educational credentials as outlined. The successful candidate will lead validation activities, prepare risk assessments, and ensure regulatory compliance across pharmaceutical, medical devices, and chemical industries.

Qualifications

  • Education requirements as listed: Doctorate/Master/Bachelor/Associates/HS with years of related experience.
  • Bilingual (English & Spanish).
  • Experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, GDP, Change Controls, SOPs.

Skills

Commissioning & Qualification
Equipment validation
GDP (Good Documentation Practices)
Change controls
SOPs
Bilingual English/Spanish

Education

Doctorate + 2 years related experience
Master's + 4 years related experience
Bachelor's + 6 years related experience
Associates + 10 years related experience
High school/GED + 12 years related experience

Tools

Kneat
QRAES

Job description

QRC Group, LLC seeks a Sr. Specialist QA with proven expertise in commissioning and qualification, equipment validation, QRAES, Kneat, GDP, change controls, and SOPs.

The role requires bilingual English/Spanish communication and advanced educational credentials as outlined. The successful candidate will lead validation activities, prepare risk assessments, and ensure regulatory compliance across pharmaceutical, medical devices, and chemical industries.

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