Senior QA Specialist – Compliance & CAPA Lead

Validation & Engineering Group, Inc.; Barceloneta (PR); Vor Ort; USD 60.000 - 90.000; Vollzeit

Zusammenfassung

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a QA Specialist III to implement and maintain the Quality System, support manufacturing events, and guide investigations and risk evaluations.

The role involves ensuring regulatory compliance across QA activities and coordinating with plant departments to uphold quality standards. Ideal candidates possess a biotechnical or engineering background, 4+ years in pharma/biotech, and strong writing and communication skills in

Qualifikationen

• Bachelor's degree in biotechnology, biology, chemistry or engineering.
• Four (4) years of experience in pharmaceutical/biotechnology industry in a similar position.
• Knowledge of GMP, safety regulations and cGxP.
• Excellent written and spoken English and Spanish.
• Proficient using MS Windows and Microsoft Office applications.
• Strong investigations, technical writing and risk-based evaluation skills.

Aufgaben

• Support routine operations to meet quality goals and comply with regulations.
• Serve as backup for QA Manager and lead quality initiatives.
• Ensure investigations of plant events are evaluated promptly and documented in CAPA system.
• Perform product impact analyses and hold products as needed.
• Participate on the Validation Review Board and approve QA documents.
• Assist in change management, calibration approvals, and maintenance records.
• Promote EHS compliance and coordinate with other quality areas and plant departments.

Kenntnisse

Bilingual English/Spanish

MS Windows

Microsoft Office

Regulatory knowledge

Investigations processes

Technical writing

Teamwork & time management

Ausbildung

Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering

Master's degree in Science preferred

Tools

CAPA system

Jobbeschreibung

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a QA Specialist III to implement and maintain the Quality System, support manufacturing events, and guide investigations and risk evaluations.

The role involves ensuring regulatory compliance across QA activities and coordinating with plant departments to uphold quality standards. Ideal candidates possess a biotechnical or engineering background, 4+ years in pharma/biotech, and strong writing and communication skills in