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External Supply Specialist – Medical Device  (JP7565)

BUFFALO GROVE, IL · Biotech/Pharmaceutical
Job Title:  External Supply Specialist – Medical Device  (JP7565)
Location: BUFFALO GROVE, IL 60089 (Essential Worker - Onsite)
Employment Type:  Contract
Business Unit: Electro-Mechanical Device External Supply
Duration: 4 months
Posting Date: 8/11/20
 
3 Key Consulting is hiring an External Supply Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:

Person-In-Plant (PIP) Roles and Responsibilities:
 
CONTRIBUTE TO THE MATURITY LEVEL AT COMPANY SUPPLIERS
  • 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.
     
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 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.
 
ENHANCE CROSS COMPANY COMMUNICATION & RELATIONSHIP
  • 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.
 
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.
   
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:
phone/skype 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 welcome to 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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