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Specialist Quality Assurance (JP7155)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Specialist Quality Assurance (JP7155)
Location: Thousand Oaks, Ca
Employment Type:  Contract
Business Unit:  Electro-Mechanical Device External Supply
Duration: 6+ months (with likely extensions)
 
3 Key Consulting is hiring a Specialist Quality Assurance for a consulting engagement with our client, a leading global biopharmaceutical company.
 
Job Description:
* Must be able to work M-F, hours are flexible based on candidate schedule.
* Be Located or able to commute to Buffalo Grove, IL.
 
Our ideal candidate will have a bachelor’s degree in Mechanical Engineering or related field. Plus 5 years of relevant experience.  Person-in-Plant (PIP) responsibilities include:
 
CONTRIBUTE TO THE MATURITY LEVEL AT AMGEN SUPPLIERS
  • Ensure successful execution of cGMP compliant manufacturing activities at suppliers according to the Quality Agreement approved by Amgen 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 Amgen 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 Amgen 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 Amgen 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.
 
Why is the Position Open?
Supplement additional workload.
 
 
Top 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.
 
 
Employee Value Proposition:
Chance to work on communication and influencing skills with an outside vendor.
 
 
Red Flags:
  • Someone with short tenure.
  • No bachelor's degree.
  • Someone who is not able to work independently.
  • No experience in a cGMP Environment.
 
 
Interview process:
Phone screening followed by in-person 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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