- Title: Product Quality Specialist
- Code: RCI-7155
- Location: Buffalo Grove Illinois (IL) 60089
- Posted Date: 03/25/2020
- Duration: 6 Months
Talk to our Recruiter
- Name:Mangesh Kanade
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 260
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