Senior Quality Assurance Auditor

About the role

Kelly Science, Engineering, Technology & Telecom is seeking a Senior QA Auditor for a biotechnology industry client in Juncos, Puerto Rico. The role serves as the Quality Assurance technical lead, providing oversight and approval of manufacturing processes, validation activities, investigations, and quality.

Responsibilities

• Audit and support manufacturing processes, process validation, equipment qualification, facilities and utilities commissioning and qualification, and Computer System Validation (CSV).
• Lead audit investigations, assess compliance issues, perform risk assessments, and drive corrective and preventive actions (CAPAs).

Requirements

• Doctorate with 2+ years, Master’s with 4+ years, or Bachelor’s with 6+ years of directly related Quality Assurance, Validation, or Manufacturing experience; degrees in Life Science or Engineering.
• Strong knowledge of GMP regulations, Good Documentation Practices, Data Integrity, Quality Systems, Change Control, Risk Management, and validation lifecycle activities.
• Experience with quality and manufacturing systems such as KNEAT, CDOCS, SCADA, TrackWise, Maximo, or similar platforms.
• Strong technical documentation and written and verbal communication skills in English and Spanish.

Benefits

• Competitive pay rate and opportunity for professional growth.
• Bi-weekly pay by W-2; vacations, sick leave, and holidays paid.
• Christmas bonus; must comply with minimum established requirements to qualify.

How to apply

Apply directly on CazVid.

Datos clave

• Administrative 8-hour shift with schedule flexibility as required to support 24/7 operations.
• Occasional after-hours engineering coverage is required.
• Requires a qualifying degree and directly related Quality Assurance, Validation, or Manufacturing experience.
• Strong written and verbal communication skills in English and Spanish are required.