Senior QA Auditor: GMP & Validation Lead in Biotech

Kelly Science, Engineering, Technology & Telecom; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Bi-Weekly pay by W-2

Christmas bonus

Job summary

Kelly Science is seeking a Senior QA Auditor in Juncos, PR to lead quality assurance activities in a biotech manufacturing setting. The role requires oversight of GMP compliance, quality systems, and validation life cycle, with responsibility for audits, investigations, and CAPAs.

You will collaborate with cross-functional teams, review validation protocols and reports, support process improvements, and ensure data integrity across manufacturing operations.

Qualifications

• Doctorate with 2+ years, Master’s with 4+ years, or Bachelor’s with 6+ years in QA/validation/manufacturing.
• Strong knowledge of GMP, Data Integrity, Quality Systems, Change Control, Risk Management and validation lifecycle.
• Experience auditing and supporting manufacturing processes, validation, equipment qualification, facilities/utilities commissioning and CSV.
• Demonstrated ability to lead audit investigations and drive CAPAs.
• Experience with KNEAT, CDOCS, SCADA, TrackWise, Maximo or similar platforms.
• Excellent written and verbal communication in English and Spanish.

Responsibilities

• Lead QA audits and investigate compliance issues.
• Review manufacturing processes and validation activities.
• Approve quality systems, CAPA and change controls.
• Provide data analysis and interpretation for projects.
• Collaborate with cross‑functional teams to ensure GMP compliance.

Skills

QA auditing

GMP compliance

Data integrity

Documentation

Risk assessment

CAPA leadership

Biotech manufacturing

English & Spanish

Education

Bachelor’s in Life Science or Engineering

Master’s in Life Science or Engineering

Doctorate in Life Science or Engineering

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

Kelly Science is seeking a Senior QA Auditor in Juncos, PR to lead quality assurance activities in a biotech manufacturing setting. The role requires oversight of GMP compliance, quality systems, and validation life cycle, with responsibility for audits, investigations, and CAPAs.

You will collaborate with cross-functional teams, review validation protocols and reports, support process improvements, and ensure data integrity across manufacturing operations.