Manufacturing Investigations & Continuous Improvement Specialist

Responsibilities

• Lead end-to-end cGMP investigations (deviations, non-conformances, complaints) with a focus on root cause identification, risk mitigation, and prevention of recurrence
• Apply structured root cause methodologies (e.g., 5 Whys, Fishbone, FMEA) to identify systemic issues and drive continuous improvement
• Develop, implement, and track CAPAs, ensuring effectiveness, sustainability, and measurable outcomes
• Analyze and trend data to identify recurring issues and improvement opportunities
• Evaluate and collaborate on cGMP-compliant documentation, including SOPs, production records, studies, validation protocols, and reports
• Initiate and manage change controls in support of process, equipment, and continuous improvement initiatives
• Ensure documentation meets cGMP and FDA regulatory expectations, with a focus on clarity, accuracy, and compliance
• Partner with Manufacturing, Engineering, MSAT, Facilities, Finance and Quality to implement process improvements
• Contribute to inspection readiness by maintaining high-quality investigation and documentation standards
• Lead interdepartmental continuous improvement initiatives

Requirements

• Bachelor's degree in biology, Chemistry, Engineering, or related scientific discipline
• 5+ years of experience in investigations in a cGMP manufacturing, quality, or continuous improvement role (CMO/CDMO experience preferred)
• Demonstrated experience leading GMP investigations and authoring deviations, non-conformances, complaints, CAPAs, and change controls
• Strong technical writing skills with the ability to translate complex technical information into clear, compliant documentation
• Hands-on experience with root cause analysis tools (5 Whys, Fishbone, FMEA) and data trending/metrics analysis
• Working knowledge of cGMP regulations, FDA expectations, and Quality Systems
• Proven ability to collaborate effectively in a cross-functional, onsite manufacturing environment
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Experience with eQMS/document management systems (MasterControl preferred)
• Experience in a contract manufacturing (CDMO/CMO) environment supporting multiple clients