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External Supply Specialist (JP7822)

Buffalo Grove, IL · Biotech/Pharmaceutical
Job Title:  External Supply Specialist (JP7822)
Location: Buffalo Grove, IL . 60089 (Onsite Essential)
Employment Type:  Contract
Business Unit: Electro-Mechanical Device External Supply
Duration: 6+ months (with likely extensions)
Posting Date: 10/15/20
 
 
3 Key Consulting is hiring an External Supply Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
 
Job Description:
  1. 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.
 
  1. 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.
 
  1. ENHANCE CROSS COMPANY COMMUNICATION & RELATIONSHIP
  • 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.
 
 
Why is the Position Open?
Additional workload on the team.
 
 
Top Must-Have Skill Sets:
  • 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.
 
 
Day to Day Responsibilities:
See above.
 
Employee Value Proposition:
Chance to work on communication and influencing skills with an outside vendor
 
Red Flags:
No experience in a cGMP Environment
  • Someone with short tenure.
  • No Bachelor's degree.
  • Someone who is not able to work independently.
 
 
Interview process:
Video Skype Panel Interview.
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.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.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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