QC Investigations Expert (Onsite)

Job Description Quality Assurance Specialist - Cell Therapy Manufacturing About the Role We are seeking a motivated Quality Assurance (QA) professional to support GMP manufacturing operations in our cell therapy environment. This role offers the opportunity to directly impact patient safety and product quality by ensuring compliance with global regulatory standards and driving a culture of continuous improvement. As a QA Specialist, you will provide oversight of manufacturing operations, support quality systems, and collaborate cross-functionally to uphold the highest standards of cGMP compliance. Key Responsibilities • Provide quality assurance oversight of manufacturing operations to ensure GMP compliance. • Support continuous improvement initiatives through participation in deviation investigations, CAPA management, and change control. • Lead and contribute to Quality Management Reviews (QMRs), analyzing key quality metrics including deviations, CAPAs, audit findings, and complaints. • Collaborate effectively with cross-functional teams (Quality, Manufacturing, Validation, and Regulatory) to resolve issues and maintain compliance. • Review, author, and maintain Standard Operating Procedures (SOPs) in alignment with regulatory expectations. • Conduct and support thorough investigations (OOS, OOE, OOT, RCA studies), ensuring timely resolution and documentation. • Apply data integrity principles and contribute to compliance with FDA, EMA, and ICH guidelines. • Communicate clearly with management on progress, risks, and resource needs. • Prioritize workload effectively across multiple programs in a dynamic, fast-paced environment. Essential Requirements • Bachelor's degree with 2-4 years of pharmaceutical/biopharmaceutical experience, or Master's degree with 2-3 years. • Minimum 2 years of hands-on experience in a cGMP environment within commercial manufacturing. • Strong knowledge of cGMP regulations and global quality standards (FDA, EMA, ICH, EU). • Direct experience with QA oversight and Quality Management Systems (QMS), preferably in cell therapy manufacturing or QC operations. • Proven ability to author, review, and implement SOPs. • Strong written and verbal communication skills, with technical writing expertise. What We're Looking For • A proactive team player with strong problem-solving skills. • Someone who thrives in a collaborative, high-paced environment and is eager to contribute to life-saving therapies. • A quality-driven mindset with a passion for maintaining compliance while supporting innovation in advanced therapies. Apply tot his job