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Quality Complaints Senior Associate - Biopharma (JP8099)

Thousand Oaks, CA · Biotech/Pharmaceutical

Job Title: Quality Complaints Senior Associate - Biopharma (JP8099)
Location: Thousand Oaks, CA (Remote until Convid-19 restrictions are lifted)
Business Unit: Electro-Mechanical Complaints 
Employment Type: Contract
Rate: $26-30/Hr.
Duration: 12 months with likely extensions
3 Key Consulting is hiring a Sr Associate Quality Complaints position for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Initiate and coordinate product complaints. Interface with call centers, various company sites and business partners to ensure call intake process compliance.
  • Complete and approve product complaints requiring no further investigation.
  • Reconcile reported product complaints to ensure entry in CMIS.
  • Perform return sample coordination and visual assessment.
  • Archive documents related to product complaints. Evaluate documentation and operation and documentation according to company guidelines.
  • Be self-motivated, attentive to details and able to prioritize and meet deadlines.
  • Basic statistical mathematical skills including the ability to trend data.
  • Basic project management skills. Independently understand, follow and implement instructions. Strong word processing, database and spreadsheet application skills.
  • Strong organizational skills with the ability to manage multiple projects or assignments.
Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and/or experience. Typically, 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry.

Top Must have Skill Sets:
  • Prior quality experience
  • Strong computer skills (Microsoft)
  • Good communication skills
  • Good organizational skills
Day-To-Day Responsibilities:
  • Triage incoming complaint records by reviewing information, assigning complaint codes and assessments, and determining if further information is required.
    Understand basic device operation to determine complaint codes.
  • Coordinate/follow-up with other departments for required information.
  • Ensure fields are populated correctly. Manage workload to ensure timeframes are met.
Employee Value Proposition:
Good understanding over the overall complaints system.
Interview Process: 
Phone screen then panel WebEx/Skype interview.
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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