Description
PLEASE READ:
- Please submit candidates that have experience with implementing or improving GMP at a facility.
- A candidate who worked in a GMP environment does not mean this person is qualified for this role (ie do not submit warehouse associates, shipping/receiving clerks, purchasing agents, buyers, material handlers, etc )
- Experience with Oracle is another major requirement for this role. Please make sure to qualify your candidates.
- *If there is any gap of employment or short-term assignments, please provide an explanation in the submittal of the reason behind it. The manager will question gaps of employment and short-term assignments.*
Description:
- Work strategically to drive physical and systematic changes in the material flow process by deploying Lean/Six Sigma methodology.
- Manage a group of Materials Specialists.
Key responsibilities include:
As the point person for a GMP warehouse materials team, you will be responsible for:
- GMP systems and compliance
- Inventory management
- Transactional Process Support
- Lean manufacturing initiatives and support
- Establishing and maintaining a teamwork environment
Quality Specific Goals:
- Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, GMP guidelines and applicable laws and regulations as they apply to this job type/position
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Knowledge and understanding of production process work instructions and operates within them to ensure that a device conforms to its specifications
- Ensures the creation of accurate, complete and timely records and DHRs
Qualifications:
- Bachelor's degree and two years or more years of relevant experience (preferred)
- Two to five years of experience managing GMP materials management systems in a heavily regulated industry (biotechnology, pharmaceutical, medical) - MUST HAVE
- Two to five years of experience using Oracle - MUST HAVE
- Experience with setting up policies and procedures following GMP
- Proven ability to drive change initiatives in a Matrix environment
- Strong communication and management skills
Preferred Qualifications:
- Lean manufacturing experience
- MBA or Master's Degree