QA Specialist

• Responsible for ensuring compliance with all aspects of Quality inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
• Responsible for review and approval of the following types of documents: Failure investigations, Corrective and preventative actions (CAPA), Standard operating procedures (SOP's), GxP documents & Change control documents
• Provide expert input and guidance during Change Control and Deviation Review Boards.
• Management of Quality Risk Management (QRM) processes, including integration of QRM principles within quality frameworks.
• Maintain and enhance the Quality Management Review process and ensure alignment with corporate policies.
• Monitor regulatory updates and ensure that the site quality systems remain compliant and inspection-ready.
• Drive sustained compliance initiatives, including self-inspections, internal audits, and continuous improvement activities.
• Develop and manage Quality Agreements relevant to the specialist area.

• Degree in Science, Engineering, or related discipline.
• A minimum of 3-5 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
• Strong knowledge of GMP standards and regulatory requirements
• Demonstrates advanced working knowledge of QA systems principles, methods, QA concepts, industry practices and standards
• Demonstrates audit and investigation skills, and report writing skills.
• Strong written and verbal communication skills.
• Experience with root cause analysis, investigations, and problem-solving.
• Excellent understanding of regulatory expectations and inspection readiness.

Morgan McKinley