Manufacturing Specialist 1, Materials
On-siteHolly Springs, North Carolina, United States
Job Summary
Support operational readiness, site commissioning, and qualification efforts while acting as a process subject matter expert for assigned areas. Coordinate batch planning, process templates, and preventive maintenance activities alongside non-batch tasks like changeovers and column packing. Maintain accurate documentation, drive timely updates, and manage change management records, investigations, and continuous improvement projects. Assist with inventory management, technology transfers, and internal/external inspections to ensure compliance with cGMP and safety requirements. Manage corrective and preventive actions to maintain production quality and schedule adherence. Requires flexibility with working hours and shift rotation in a 24/7 facility.
Required Qualifications
- High School Diploma/GED and 10 years of related experience
- Associate's degree, preferably in life sciences or engineering, with 8 years of direct experience
- Bachelor's degree, preferably in life sciences or engineering, with 6 years of direct experience
- Equivalent military experience/training
- Flexibility with working hours and shift rotation
- Strong current Good Manufacturing Practice (cGMP) manufacturing operations experience
- Solid understanding of operations sequence and cadence of activities
- Prior experience updating and creating manufacturing documents according to schedule
- BioWorks or BTEC Capstone cGMP coursework
Desired Qualifications
- Strong verbal and written communication skills
- Excellent time management and the ability to prioritize in a fast-paced environment
- Adaptability—able to pivot and adjust plans as priorities shift
- Critical thinking and superior problem-solving skills
- A team-first mindset with the ability to work effectively in a global, cross-functional environment and build strong relationships
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