Senior QA Auditor — GMP & Validation Leader

Kelly Services; Juncos (PR); On-site; USD 55,000 - 78,000; Full time

Benefits offered by this job

Bi-Weekly pay by W-2

Medical insurance

Dental insurance

Vision insurance

Term life insurance

Short-term disability

Holidays & vacation pay

Job summary

Kelly Services is seeking a Senior QA Auditor in Juncos, PR. You will provide QA technical leadership, oversee manufacturing processes and validation activities, and ensure GMP compliance across projects.

The role requires deep experience with audit investigations, CAPAs, and systems like TrackWise and Maximo. You will collaborate with cross-functional teams to drive continuous improvement, perform risk assessments, and manage quality programs in a 24/7 manufacturing environment.

Qualifications

• Doctorate with 2+ years, Master’s with 4+ years, or Bachelor’s with 6+ years of directly related QA/Validation/Manufacturing experience.
• Strong knowledge of GMP regulations, Good Documentation Practices, Data Integrity, Quality Systems, Change Control, Risk Management, and validation lifecycle activities.
• Experience auditing/managing manufacturing processes, process validation, equipment qualification, facilities/utilities commissioning/qualification, and CSV.

Responsibilities

• Lead QA audit investigations and drive CAPAs with cross-functional teams.
• Review/approve manufacturing processes, validation protocols and reports to ensure GMP compliance.
• Provide data analysis/interpretation and assess impact of data on projects.

Skills

QA Auditor

GMP knowledge

Data Integrity

Risk Management

CAPA investigations

Process Validation

CSV experience

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 Services is seeking a Senior QA Auditor in Juncos, PR. You will provide QA technical leadership, oversee manufacturing processes and validation activities, and ensure GMP compliance across projects.

The role requires deep experience with audit investigations, CAPAs, and systems like TrackWise and Maximo. You will collaborate with cross-functional teams to drive continuous improvement, perform risk assessments, and manage quality programs in a 24/7 manufacturing environment.