Company
Operations
GMPOperationsCoordinator
“GMP Operations Coordinator. Skills: GMP operations, Inventory management, Cross-functional coordination, Troubleshooting. Support day-to-day GMP operations. Maintain GMP storage rooms”
Industry & Context.
Dynamic troubleshooting; Proactively address issues; Troubleshooting logistics; Troubleshooting issues; Scrappy problem-solving
On-call responder for facility emergencies, Rotating team responsibility includes nights, weekends, and holidays, Physically comfortable in an active role, Able to safely lift and handle materials and supplies (up to 50 lbs), Willing to occasionally work outside regular hours
What They're Looking For.
Must Have
2+ years of experience working in GMP operations, quality assurance, or another highly regulated biotech environment, Hands-on and technically adept in cleanroom environments, Practical knowledge of electronic quality management or manufacturing execution systems, Organized and precise, Communicate clearly and confidently, Embrace technology and organization, Familiar with digital tools such as Google Workspace, Asana, and Notion, Confident in picking up new systems like MasterControl, Enjoy diving into complex problems and proactively troubleshooting issues, Physically comfortable in an active role, Able to safely lift and handle materials and supplies (up to 50 lbs)
Nice to Have
Directly supported cell therapy manufacturing, Know your way around environmental monitoring equipment, Understand contamination control practices, Feel at ease maintaining meticulous documentation, Enjoy optimizing how things are tracked, stored, and managed, Take pride in maintaining clear, detailed documentation, Intuitive feel for regulatory requirements and standards, Providing updates to colleagues in non-technical roles, Track tasks and document work, Not one to wait for instructions when you spot a potential improvement or an operational snag, Using appropriate support and equipment, Flexible and willing to occasionally work outside regular hours to address critical GMP activities, emergencies, or maintenance needs, Experience with Cell therapy or biologics manufacturing, Inventory and material handling systems (Quartzy, ERP systems, etc.), Equipment qualification (IQ/OQ/PQ) support, Startup or early-stage biotech environments, Comfortable with rapid change and scrappy problem-solving, Environmental monitoring program execution
What You'll Do.
Support day-to-day GMP operations
Maintain GMP storage rooms
Monitor inventory levels and reorder points
Manage warehouse organization and material segregation
Prepare for manufacturing runs
Serve as second SciOps team member
Support electronic batch record execution
Execute routine environmental monitoring sampling
Assist with equipment performance qualification documentation
Assist with deviation and CAPA investigation logistics
Assist with training record coordination
Support vendor coordination
Provide hands-on support to SciOps team
Serve as key on-call responder
How You'll Work.
Team & Collaboration
Collaborating cross-functionally; Providing updates to colleagues
Communication Scope
Communicate clearly and confidently
Process & Methodology
Improvement projects
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