Quality Assurance Specialist

About the role

The Quality Assurance Specialist will support the QA program for a leading biopharmaceutical client in Puerto Rico. Working under minimal supervision, the role ensures compliance with regulatory standards, validates manufacturing processes, and maintains high‑quality standards across the site.

Key responsibilities

• Review and approve deviations, critical utilities, and environmental monitoring trend reports.
• Approve product manufacturing procedures (MPs) and process validation protocols and reports.
• Participate in incident triage, approve planned incidents, and represent QA on New Product Introduction (NPI) teams.
• Conduct investigations, audits, and risk assessments; own site quality program procedures.
• Serve as designee for the QA manager on the local CCRB and approve environmental characterization reports.
• Support automation validation activities and facilities/environmental programs.
• Review and approve work orders, non‑conformance investigations, CAPA records, and change controls.

Required profile

• High school/GED with 10 years of related experience, or associate degree with 8 years, or bachelor’s degree with 4 years, or master’s degree with 2 years of directly related experience.
• Bachelor’s degree in a scientific discipline (e.g., Engineering, Biology, Chemistry, Physics, Computer Science) is preferred.
• More than 10 years in the biopharmaceutical industry, including at least 5 years in Quality Assurance.

Required skills

• Quality and compliance expertise
• Regulatory audit experience
• Process validation and protocol development
• Characterization and automation validation
• CAPA (Corrective and Preventive Action) management
• Change control procedures
• Environmental monitoring and utility approval
• Risk assessment and incident triage