Quality Specialist, QA Qualification

About the role

Lonza is hiring a Quality Specialist for its Quality Assurance team in San Jose, Costa Rica. The role ensures the compliance, qualification and validation of equipment and computerized systems used in pharmaceutical manufacturing, influencing global engineering projects and upholding regulatory excellence.

Key responsibilities

• Provide Quality Assurance oversight for qualification and validation of equipment and computerized systems in cGMP manufacturing environments.
• Act as the QA representative on cross-functional project teams, ensuring GMP compliance throughout all phases.
• Review and approve commissioning, qualification and validation protocols, reports, risk assessments and technical documentation.
• Partner with Global Engineering, Commissioning & Qualification (C&Q), Computer System Validation (CSV) and Quality teams to align quality standards.
• Assess new regulatory requirements and turn them into practical quality and compliance improvements.
• Support regulatory inspections, customer audits, process qualification activities and responses to regulatory inquiries.
• Drive data integrity and continuous improvement initiatives in line with Lonza policies, industry standards and global GMP regulations.

Required profile

• Experience in Quality Assurance, qualification, commissioning, validation or compliance in a GMP-regulated pharmaceutical, biotechnology or life sciences environment.
• Bachelor's degree (Biological, Chemical, Bioprocess or related discipline) or a comparable scientific field preferred.
• Business-fluent English and a continuous improvement mindset.

Required skills

• Understanding of qualification and validation processes for equipment and computerized systems.
• Knowledge of cGMP principles and regulatory requirements such as FDA and EU GMP.
• Ability to review technical documentation, assess risks and give quality guidance to cross-functional stakeholders.
• Strong communication and collaboration skills across global teams.

What we offer

• An agile career and dynamic working culture in an inclusive, ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to contribute to global projects and cross-functional initiatives.
• Career development through exposure to engineering, quality, validation and regulatory disciplines.
• A variety of benefits depending on role and location.