External Supply Specialist (JP7822)
Buffalo Grove, IL . 60089 (Onsite Essential)
Electro-Mechanical Device External Supply
6+ months (with likely extensions)
3 Key Consulting is hiring an External Supply Specialist
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
- CONTRIBUTE TO THE MATURITY LEVEL AT CLIENT'S SUPPLIERS
- Ensure successful execution of cGMP-compliant manufacturing activities at supplier’s location according to client-provided checklist and through knowledge of agency expectations and compliance with applicable regulations.
- Identify/monitor improvement opportunities and assist in on-site investigations at the supplier’s facility as directed by client site quality leader (determined as needed).
- Represent client in manufacturing operations at the supplier’s facility to ensure error-proof production activities.
- Confirm that the supplier’s supply chain task execution is in alignment with client expectations.
- Execute tasks per the client-provided checklist.
- MONITOR AND IMPROVE THE SUPPLIER PERFORMANCE AND RISK SURVEILLANCE
- Build a good understanding of supplier’s raw materials, molding (experience a plus), assembly, and processing equipment.
- Proactively engage in the production steps to obtain working knowledge of floor challenges / support needed.
- Assess risk by the active collection of feedback on supplier’s performance. Input to be incorporated into supplier oversight practices.
- Communicate issues/updates/decisions on key deliverables and activities to client throughout the manufacturing process (including pre and post); consistently engage client core team members/Management.
- Prior to any run - evaluate site production readiness per client-provided checklist.
- ENHANCE CROSS COMPANY COMMUNICATION & RELATIONSHIP
Why is the Position Open?
- Ensure immediate assistance and communication to client in case of any unexpected event.
- Support triage of investigations and/or deviations to ensure communication and acceptable mitigation strategies as deemed appropriate by client.
- Provide updates/summary reports of supplier’s performance, related to client’s checklist, to the client team at a minimum of weekly (past highlights/lowlights, forward looking).
- Be present at supplier’s facility to observe unit operations and review documentation as deemed necessary.
- During the run – be engaged in production progress and with identifying early warning signs; suggest corrective actions real-time.
Additional workload on the team.
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- Experience working in cGMP production environments including direct support with cGMP manufacturing processes (production and quality background).
- Understanding and proven real-life application of regulations in a cGMP Environment.
- Strong interpersonal skills; comfortable communicating with both internal team and external clients.
Employee Value Proposition:
Chance to work on communication and influencing skills with an outside vendor
No experience in a cGMP Environment
- Someone with short tenure.
- No Bachelor's degree.
- Someone who is not able to work independently.
Video Skype Panel Interview.
We invite qualified candidates to send your resume to email@example.com
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.