Job Details

  • Title: Product Quality Specialist
  • Code: RCI-7155
  • Location: Buffalo Grove Illinois (IL) 60089
  • Posted Date: 03/25/2020
  • Duration: 6 Months
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  Job Description

Description:

Ideal candidate- Looking for Bachelors Degree in Mechanical Engineering or related field. Plus 5 years of relevant experience

Person-In-Plant (PIP) Roles and Responsibilities

CONTRIBUTE TO THE MATURITY LEVEL AT client SUPPLIERS
  • Ensure successful execution of cGMP compliant manufacturing activities at suppliers according to the Quality Agreement approved by client and through knowledge of agency expectations and compliance with regulations.
  • Review production readiness, identify/monitor improvement opportunities, and assist in on-site investigations as needed
  • Represent client at the supplier’s manufacturing operations to ensure error-proof production activities.
  • Confirm suppliers material management readiness.

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 performance. Input to be incorporated into supplier oversight practices.
  • Communicate issues/updates/decisions on key deliverables and activities throughout the manufacturing process (including pre and post) -Engage client core team members/Management as appropriate.
  • Prior to any run -evaluate site production readiness to ensure success.

ENHANCE CROSS COMPANY COMMUNICATION & RELATIONSHIP
  • Ensure immediate assistance on site in case of any unexpected event.
  • Support triage of investigations and/or deviations to ensure communication and acceptable mitigation strategies.
  • Provide updates/summary reports to client team at a minimum of weekly (past highlights/lowlights, forward looking).
  • Be present at suppliers site for unit operations and review documentation as deemed necessary
  • During the run – be engaged in production progress and identifying early warning signs and suggest corrective actions real-time.

Must Have Skill Sets:
  • Quality Assurance experience with cGMP production environments; direct work experience with cGMP processes involved in manufacturing
  • Understanding and proven real-life application of regulations in a cGMP Environment
  • Strong interpersonal skills; comfortable communicating with both internal team and external clients