Quality Assurance Specialist, Raw Materials & Supplier QualityAbout the Role We are seeking a Quality Assurance Specialist, Raw Materials & Supplier Quality to support the quality oversight of raw materials and consumables used in clinical and commercial manufacturing operations. Reporting to the Senior Manager, Global Product Quality Materials, this individual will play a key role in ensuring raw material quality, supplier compliance, and regulatory adherence across the supply chain. The successful candidate will collaborate closely with cross-functional teams including Manufacturing Science & Technology (MS&T), Process Development, Analytical Development, Supply Chain, Manufacturing, Regulatory Affairs, Quality Control, and external suppliers to ensure robust raw material quality systems are maintained and continuously improved. Key Responsibilities Support supplier qualification, onboarding, and material supplier management activities for raw material and consumable suppliers. Participate in supplier change notification processes, evaluating changes for potential product and process impact through risk-based assessments. Manage supplier quality issues by initiating supplier complaints and supporting the Supplier Corrective Action Request (SCAR) process through resolution and corrective action implementation. Assist with the development, execution, maintenance, and tracking of supplier quality agreements. Support raw material qualification programs for materials used in both clinical and commercial manufacturing. Ensure raw material onboarding activities comply with applicable GxP regulations, regulatory requirements, and company quality standards. Participate in change controls, deviations, CAPAs, investigations, and related quality system activities involving raw materials. Review quality plans and support implementation of quality initiatives. Conduct or support root cause investigations and effectiveness checks for corrective actions. Monitor supplier and material quality performance, identifying opportunities for continuous improvement. Ensure adherence to all applicable GxP regulations, company procedures, and industry standards. Execute responsibilities in accordance with SOPs, work instructions, and quality system requirements. Maintain accurate documentation in compliance with Good Documentation Practices (GDP) and Data Integrity standards. Support audit and inspection readiness by ensuring records and quality documentation are complete and maintained. Complete all required training and maintain qualifications as required. Required Qualifications Bachelor's degree in a Scientific, Engineering, Life Sciences, or related discipline. 2-5+ years of experience within the pharmaceutical, biotechnology, biologics, or related regulated industry. Exposure to Quality Assurance, Supplier Quality, Raw Material Quality, or Quality Systems activities. Understanding of or demonstrated ability to learn GxP regulations and quality requirements. Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment. Excellent written and verbal communication skills. Ability to collaborate effectively across cross-functional teams and with external suppliers. Preferred Qualifications Experience with supplier qualification and supplier quality management programs. Knowledge of change control, deviations, investigations, CAPA, and quality risk management processes. Familiarity with GMP manufacturing environments and raw material lifecycle management. Experience supporting regulatory inspections and/or supplier audits. Understanding of data integrity requirements and Good Documentation Practices (GDP). Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.