Senior Quality Assurance Auditor

About the role

The Senior Quality Assurance Auditor will act as the technical lead for QA, overseeing manufacturing processes, validation activities, investigations and quality systems for a biotechnology client in Juncos, PR. The role supports 24/7 operations with occasional after‑hours coverage and contributes to a culture of safety, innovation and operational excellence.

Key responsibilities

• Provide oversight and approval of manufacturing processes, validation protocols, environmental reports and sanitary utility releases.
• Lead audit investigations, assess compliance issues, perform risk assessments and drive corrective and preventive actions (CAPAs).
• Partner with cross‑functional teams to ensure GMP compliance, support new product introductions and manage quality risks.
• Design, monitor and conduct experimental strategies, analyze data and interpret results for impact on projects.
• Maintain site quality programs, represent QA on governance boards and ensure continuous improvement across operations.

Required profile

• Doctorate (2+ yr), Master’s (4+ yr) or Bachelor’s (6+ yr) in Life Sciences or Engineering with directly related QA, validation or manufacturing experience.
• Strong knowledge of GMP regulations, Good Documentation Practices, Data Integrity, Quality Systems, Change Control, Risk Management and validation lifecycle activities.
• Experience auditing manufacturing processes, process validation, equipment qualification, facilities/utilities commissioning and Computer System Validation (CSV).
• Proven ability to lead investigations, assess compliance, perform risk assessments and implement effective CAPAs.
• Fluent in English and Spanish with strong technical documentation skills.

Required skills

• KNEAT
• CDOCS
• SCADA
• TrackWise
• Maximo
• Computer System Validation (CSV)
• GMP regulations
• Good Documentation Practices
• Data Integrity
• Change Control
• Risk Management
• Validation lifecycle

What we offer

• Competitive $48 /hr pay rate with bi‑weekly W‑2 payments.
• Opportunities for professional growth and work with a leading organization in the manufacturing sector.
• Paid vacations, sick leave, holidays and a Christmas bonus.