Quality Assurance Specialist

Key Responsibilities: Investigate and document deviations and nonconforming events across multiple technical departments Gather and analyze data to support root cause investigations using tools such as 5 Whys and Fishbone Collaborate with Manufacturing, Engineering, MS&T, Supply Chain, and Quality teams to ensure accurate and thorough investigations Translate complex technical processes into clear, concise investigation reports and documentation Develop and support corrective and preventative actions (CAPA) to address root causes and prevent recurrence Review historical deviations and quality events to identify trends and support continuous improvement Maintain documentation within electronic Quality Management Systems (eQMS) and ensure compliance with GMP standards Qualifications: Bachelor’s degree in a scientific, engineering, or technical discipline 2+ years of experience in quality assurance or technical writing within a GMP-regulated environment (pharmaceutical, biotech, or biologics preferred) Experience with deviation investigations, root cause analysis, and CAPA development Strong understanding of GMP manufacturing processes and regulatory requirements Excellent technical writing, documentation, and communication skills Proficiency with Microsoft Word and Excel, and familiarity with electronic document management systems (EDMS) or eQMS Strong organizational skills and attention to detail, with the ability to collaborate across teams #J-18808-Ljbffr Harba Solutions Limited