Specialist Product Quality – Biotech (JP4643)

Location: Thousand Oaks, CA
Date Posted: 08-22-2018
Job Title:  Specialist Product Quality – Biotech (JP4643)
Location: Thousand Oaks, Ca
Employment Type: Contract
Duration: 1 Year with likely extension.
Business Unit: Corporate Product Quality
3Key Consulting is looking for an Product Quality Specialist for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA
Manage the development and implementation of clinical and commercial product specifications, in process control documents, and other specification related documents.  Facilitation of specification development meetings and the generation of detailed and communicate meeting minutes/action items to all attendees.  Other tasks include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner.  Own nonconformance records (NC), and lead or coordinate activities required to advance NCs to closure.  Implement and maintain a product quality data tracking system that facilitates meaningful analysis of release and in process test results (data mining).  Additional responsibilities include assisting Product Quality leader function by facilitating team meetings and drafting/distributing meeting minutes, assisting in the management of product sample plans, as well as other assignments and projects as assigned.
Required Skills:
  • Bachelors degree with 5 years experience or Masters with 2 years experience in biopharmaceutical industry
  • experience using computer software such as MS Office (i.e. Excel, Word, Project)
Top Must Have Skill Sets:
GMP Experience Project Experience in a biopharmaceutical company Quality experience
Employee Value Proposition:
This person would obtain broad quality experience with a large portfolio of products. Exciting work environment.
Red Flags:
Not enough work experience in a pharmaceutical company in a quality role
Interview Process:
30 minute phone screen with a 1 hour in-person interview Available to begin interviewing ASAP
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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