- Support business development and growth of GMP Regulated Services business units and Critical Environments
- Support multiple projects concurrently using operations experience focused on GMP compliance and process excellence
- Apply industry best-known methods, Lean Six Sigma methodologies, and improvement tools
- Manage and coordinate services and projects
- Provide technical mentoring to department personnel
- Coordinate GMP Regulated service initiatives with functional area leaders
- Provide data for budgets and help manage multiple cost centers while ensuring compliance
- Complete performance appraisals for direct reports and review staff appraisals
- Create, develop, update, revise, and maintain documentation, policies, programs, procedures, and files
- Ensure compliance with service/project-related regulatory requirements
- Evaluate, select, and implement business solutions and process improvements
- Develop processes, services, and tools to improve efficiency and control costs
- Maintain accurate business documents in accordance with policies and regulations
- Develop or revise task instructions and operational procedures
- Provide updates to appropriate personnel
- Assist with or lead new service introductions and account transitions
- Interact with functional representatives during business-solution selection and implementation
- Communicate business-solution information to functional departments
- Support efficient manufacturing flow design using applicable state-of-the-art technology
- Provide support and training to service personnel and customers
- Implement special projects and assignments
- Coordinate staff travel to other facilities for meetings, service or technology transfers, improvement teams, and Critical Environment training
- Travel to support operational initiatives up to 50% of the time
Requirements
- Bachelor’s degree in Business, Engineering, or related field from a four-year college or university, or equivalent combination of education and experience
- May be required to have a valid driver’s license
- Ability to perform essential duties safely and satisfactorily
- Ability to sit and talk or listen frequently
- Ability to lift and/or move up to 35 pounds
- Knowledge and ability required to manage critical-environment services and projects
- GMP compliance and regulatory-requirement knowledge
- Lean Six Sigma methodologies and tools
- Ability to develop and implement business solutions and process improvements
- Ability to create and maintain operational documentation and procedures
- Ability to travel up to 50% of the time and coordinate staff travel
Core Competencies
Demonstrates expertise in GMP Compliance and Lean Six Sigma methodologies to drive process improvements and operational excellence. Capable of managing critical-environment services and projects while ensuring adherence to regulatory requirements and effective documentation practices.
Highest-signal resume keywords
- GMP Compliance
- Lean Six Sigma Methodologies
- Project Management
- Business Solutions Development
- Operational Documentation
ATS Optimization Keywords
Hard Skills
- GMP Compliance
- Lean Six Sigma Methodologies
- Project Management
- Business Solutions Development
- Operational Documentation
- Process Improvement
- Data Analysis
- Budget Management
- Performance AppraisalCritical Environment Services Management
Soft Skills
- Technical Mentoring
- Communication
- Team Coordination
- Training
- Interpersonal Skills
Industry Keywords
- GMP Regulated Services
- Regulatory Requirements
- Process Excellence
- Operational Procedures
- Business Development
- Cost Control
- Service Initiatives
- Manufacturing Flow Design
- Documentation Management
- Staff Travel Coordination