Senior QA Auditor - Biotech | Lead Validation & CAPA

Kelly Services; Juncos (PR); On-site; USD 56,000 - 76,000; Full time

Benefits offered by this job

Bi-Weekly pay

Paid time off

Christmas bonus

Job summary

Kelly Services is seeking a Senior QA Auditor for a biotechnology client in Juncos, PR. The role focuses on leading QA activities, ensuring GMP compliance, and supporting 24/7 manufacturing operations while coordinating with cross-functional teams.

The position requires strong knowledge of validation, data integrity, and quality systems, with experience in audits and CAPA. Fluency in English and Spanish is preferred for effective collaboration.

Qualifications

• Experience in QA, validation or manufacturing within biotech or pharma.
• Knowledge of GMP, data integrity, change control and risk management.
• Experience auditing manufacturing processes and CSV would be advantageous.
• Strong documentation and bilingual communication abilities (English/Spanish).
• Leadership in audit investigations and CAPA implementation.

Responsibilities

• Serve as QA technical lead for manufacturing processes and validation.
• Oversee investigations, audits, and quality system compliance.
• Review protocols, reports, and environmental characterization data.
• Collaborate with cross-functional teams to drive CAPA and continuous improvement.

Skills

GMP regulations

Data Integrity

Quality Systems

Audit investigations

CAPA

Risk assessment

Process validation

English

Spanish

Education

Bachelor’s degree in Life Science or Engineering

Master’s degree preferred

Doctorate with 2+ years experience

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

Kelly Services is seeking a Senior QA Auditor for a biotechnology client in Juncos, PR. The role focuses on leading QA activities, ensuring GMP compliance, and supporting 24/7 manufacturing operations while coordinating with cross-functional teams.

The position requires strong knowledge of validation, data integrity, and quality systems, with experience in audits and CAPA. Fluency in English and Spanish is preferred for effective collaboration.