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Process Optimization Specialist (JP8069)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Process Optimization Specialist (JP8069)
Location: Thousand Oaks, CA. (Remote until COVID restrictions are lifted)
Employment Type:  Contract
Business Unit: Digital Health and Diagnostics Quality
Duration: 6+ months (with likely extensions)
Posting Date: 12/1/20
 
 
3 Key Consulting is hiring a Process Optimization Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
***Remote until COVID restrictions are lifted***
***Pharma or any regulated industry preferred***
 
Responsible to ensure quality and compliance associated with regulated activities at client’s affiliates / service providers by assessing / evaluating current processes, leading cross functional teams to identify issues and drive successful implementation of changes while maintain compliance to regulations using a scalable approach and align with overall corporate strategy.
 
 
Day to Day Responsibilities:
  • Identify process improvement opportunities by creating process maps
  • Lead cross-functional investigation teams in order to identify actionable root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools
  • Work in partnership with DH&DQ Leadership to forge consensus among challenging client interests while ensuring objectives are met
  • Coordinate and oversee all process changes
  • Skilled in Lean and Six Sigma techniques
  • Knowledge in Supply chain and distribution processes
  • Review procedures and work instructions
 
 
Basic Qualifications:
  • Root Cause Analysis Tools. E.g.- Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.)
  • Experience with Quality Management Systems and related standards and regulations
  • Written, verbal and presentation communication skills
  • Proficient with MS word, PowerPoint, Excel and Visio
 
 
Preferred Qualifications:
  • Bachelors degree in Life sciences, Engineering, IS, or related subject area
  • 5 years of professional experience in Program Management, Operational Excellence, Quality, R&D, Production
  • Strong project management skills / ability to lead and/or lead all aspects of multiple projects simultaneously
  • General knowledge of cGxP regulations, practices, and trends pertaining to medical device quality
  • Demonstrated strong leadership, negotiation and influencing skills along with advanced communication and analytical skills
  • Effective and timely decision making and influencing skills
  • Executive management communication experience
 
 
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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