Specialist QA – Pharmaceutical Manufacturing

About the role

We are seeking a motivated QA Specialist to join our pharmaceutical manufacturing team. You will ensure that bulk drug substances are produced, tested, stored, and released in full compliance with regulatory standards across Puerto Rico and the United States.

Key responsibilities

• Make quality disposition decisions (approval/rejection) for bulk drug substances.
• Provide quality oversight for clinical and licensed API manufacturing under cGMP and cGLP.
• Identify, investigate, document, and resolve deviations according to procedures.
• Assess changes that could impact drug substance quality and verify production records.
• Ensure facilities, equipment, materials, and processes meet regulatory and quality requirements.
• Lead continuous‑improvement initiatives and support internal/external audits.
• Support New Product Introduction activities and act as Quality representative during inspections.

Required profile

• Bachelor’s degree in Life Sciences or Engineering.
• 4+ years of QA experience in a regulated manufacturing environment.
• Full bilingual proficiency in English and Spanish.
• Ability to work independently and collaborate across all organizational levels.

Required skills

• Experience with electronic documentation platforms (e.g., CDOCS).
• Proficiency in Maximo, TrackWise, LIMS, MES/e‑batch record systems, and SAP.
• Computer Systems Validation (CSV) and GxP application validation, including Validation Master Plans, risk assessments, IQ/OQ/PQ protocols, test scripts, and approval reports.
• Strong knowledge of Quality Systems, Deviations, CAPA, and Change Control.