Co-Op, Biopharmaceutical Manufacturing Operations
Core
Support DNA manufacturing operations by managing documentation lifecycle, ensuring compliance, and driving continuous improvement initiatives in a regulated GxP environment.
Role type
Co-op Biopharmaceutical Manufacturing Operations Specialist
Builds
Reliable, compliant DNA manufacturing execution and operational performance
Domain
Biopharmaceuticals / DNA Manufacturing / GxP Compliance
Required skills
Documentation lifecycle management, GxP compliance knowledge, Process improvement, Data analysis, Cross-functional collaboration, Visual management tools
Preferred skills
GPA 3.5+, Independent work, Written/verbal communication
Technologies
Excel, Quality systems
Responsibilities
Manage documentation creation, revision, review, approval, issuance, and archival; Assist with SOPs, work instructions, and batch records; Participate in process simplification and error-proofing; Gather data for process maps and metric tracking; Develop checklists and visual management tools; Collaborate with Manufacturing, QA, QC, and Engineering teams.
Seniority
Co-op / Student