QC Compliance Specialist

Overview

We are seeking a QC compliance professional with practical experience in incoming material release, analytical method validation, and laboratory equipment qualification. The successful candidate will support quality and compliance activities within a GMP-regulated QC environment, ensuring laboratory processes, documentation, and systems meet required standards.

Key Responsibilities

• Support and coordinate incoming material release activities, including review of associated QC documentation and test status.
• Manage or contribute to the full analytical method validation lifecycle, from protocol preparation through execution, data review, reporting, and closure.
• Apply method-validation principles to raw-material testing methods, including selection and assessment of appropriate validation parameters.
• Support equipment qualification activities for laboratory equipment, including documentation review and ongoing compliance requirements.
• Prepare, review, and maintain GMP-compliant QC documentation, including protocols, reports, records, and supporting quality documents.
• Work closely with QC laboratory, Quality Assurance, warehouse/materials, and other relevant stakeholders to resolve compliance or release-related issues.
• Maintain inspection readiness and follow site quality procedures and applicable regulatory expectations.

Required Experience and Skills

• Demonstrable experience with incoming raw-material release in a GMP, pharmaceutical, biotech, or similarly regulated manufacturing environment.
• Strong working knowledge of the method validation lifecycle, including the ability to explain, plan, execute, review, or support validation work.
• Experience validating or supporting validation of raw-material analytical methods.
• Exposure to laboratory equipment qualification, including an understanding of qualification requirements across different equipment types.
• Good understanding of GMP documentation practices, data review, deviation awareness, and quality-system compliance.
• Strong attention to detail, organisation, and ability to work across multiple quality and laboratory stakeholders.
• Clear written and verbal communication skills.

Preferred Qualifications

• Degree in Chemistry, Pharmaceutical Science, Life Sciences, Biotechnology, or a related discipline.
• Experience in a QC, QA, analytical development, or validation-focused role.
• Familiarity with common validation expectations and guidance, such as ICH-aligned analytical validation principles.
• Experience working with both routine laboratory equipment and more complex analytical systems.