External Supply Specialist – Medical Device (JP7565)
BUFFALO GROVE, IL 60089 (Essential Worker - Onsite)
Electro-Mechanical Device External Supply
3 Key Consulting is hiring an External Supply Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Person-In-Plant (PIP) Roles and Responsibilities:
CONTRIBUTE TO THE MATURITY LEVEL AT COMPANY SUPPLIERS
MONITOR AND IMPROVE THE SUPPLIER PERFORMANCE AND RISK SURVEILLANCE
- Ensure successful execution of cGMP-compliant manufacturing activities at supplier’s location according to company-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 company site quality leader (determined as needed).
- Represent co 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 Company expectations.
- Execute tasks per the Company-provided checklist.
ENHANCE CROSS COMPANY COMMUNICATION & RELATIONSHIP
- 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 Company throughout the manufacturing process (including pre and post); consistently engage Company core team members/Management.
- Prior to any run - evaluate site production readiness per Company-provided checklist.
Top Must-Have Skill Sets:
- Ensure immediate assistance and communication to company in case of any unexpected event.
- Support triage of investigations and/or deviations to ensure communication and acceptable mitigation strategies as deemed appropriate by the company.
- Provide updates/summary reports of supplier’s performance, related to company’s checklist, to the 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.
- Ensure successful execution of cGMP compliant manufacturing activities at supplier’s location according to company-provided checklist and through knowledge of agency expectations and compliance with applicable regulations.
- Represent company in manufacturing operations at the supplier’s facility to ensure error-proof production activities.
- Review production readiness: identify improvement opportunities and remove roadblocks; engage key staff as appropriate.
- Confirm that the supplier’s supply chain task execution is in alignment with company expectations
- Confirm supplier’s material management readiness.
- Contribute to the implementation of meaningful metrics to track adherence to plan and overall health of the program.
- Execute tasks per the company-provided checklist.
Employee Value Proposition:
- 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.
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
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 welcome to also welcome to share this opportunity with anyone you think might be interested in applying for this role.