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