QA Specialist

As a Quality Assurance Specialist, you play a pivotal role in ensuring compliance, maintaining quality standards, and driving operational excellence across our organization. You will work closely with laboratory, manufacturing, technical, and quality teams to ensure activities are performed in accordance with GxP, ISO, and customer requirements.

More than a quality guardian, you are a trusted advisor, coach, and change agent who helps strengthen our quality culture and supports the successful delivery of high-quality services to our clients.

Responsibilities

• Ensure compliance with GxP, ISO, and internal quality standards.
• Act as a QA Subject Matter Expert (SME) for Chemistry Testing, Biosafety Testing, and/or Manufacturing Operations.
• Review, assess, approve, and close deviations, change controls, customer complaints, OOS investigations, and CAPAs in accordance with GMP requirements.
• Ensure high standards of documentation and compliance with data integrity principles.
• Support quality assurance activities and continuous improvement initiatives across the organization.
• Contribute to risk management through risk assessments, troubleshooting, and root cause investigations.
• Train, coach, and mentor colleagues while fostering a strong quality culture.
• Support digitalization and automation initiatives within Quality Assurance.
• Collaborate across departments to ensure compliance, operational efficiency, and customer satisfaction.

Tasks

• Participate in daily team meetings and contribute to operational planning and execution.
• Perform routine QA activities in accordance with SOPs and quality standards.
• Review and approve analytical protocols, equipment documentation, reports, SOPs, and Certificates of Analysis (where applicable).
• Ensure data integrity, traceability, and accuracy of records and documentation.
• Support the implementation and harmonization of QA procedures across the organization.
• Assist in the planning, preparation, hosting, and follow-up of internal, customer, and regulatory audits and inspections.
• Identify, assess, and escalate quality risks, deviations, and non-conformities.
• Support investigations, troubleshooting activities, and root cause analyses.
• Ensure customer complaints are investigated and addressed effectively.
• Collaborate with SMEs in the field of data governance.
• Act as deputy to the QA Manager for designated disciplines and responsibilities when required.
• Identify, initiate, and lead process improvement projects.
• Support the implementation of digital tools and automated QA solutions.
• Take ownership of cross-functional projects and quality initiatives