Senior QA & Compliance Lead — Investigations & CAPA

Validation-; Barceloneta (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a QA Specialist III to implement and maintain the Quality System and support manufacturing operations. You will resolve events, assess risk, review investigations, and provide guidance for product and process impact analyses.

You will also back up the QA Manager and participate in the Validation Review Board. The role requires strong English/Spanish communication, GMP knowledge, and technical writing skills, with the ability to work in a fast-paced

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering; Masters Degree in Science preferred.
• Four years of experience in Pharmaceutical/Biotechnology industry preferred.
• Knowledge of GMP, safety regulations and regulatory guidance (cGxP).
• Excellent written and spoken communication skills in English and Spanish.
• Proficient with MS Windows and Microsoft Office applications.

Responsibilities

• Support routine operations to ensure quality goals are met and procedures comply with policies and regulations.
• Lead investigations and risk assessments; approve CAPA-related documents.
• Perform product impact analyses and place products on QA hold when needed.
• Participate in Validation Review Board as Manufacturing QA function.

Skills

MS Windows & MS Office

Technical Writing

Bilingual English/Spanish

GMP knowledge

Education

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

Masters Degree in Science preferred

Job description

Validation & Engineering Group, Inc. seeks a QA Specialist III to implement and maintain the Quality System and support manufacturing operations. You will resolve events, assess risk, review investigations, and provide guidance for product and process impact analyses.

You will also back up the QA Manager and participate in the Validation Review Board. The role requires strong English/Spanish communication, GMP knowledge, and technical writing skills, with the ability to work in a fast-paced