Job Description

QA Lead Technical Operations
Job Number: 21-11676
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Lead Technical Operations for our client in Seattle, WA
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • This position is responsible for leading Product Quality Complaint (PQC) investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations.
  • This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the reported PQCs.
  • This position will lead root cause analysis sessions with site SME's and determine the associated corrective action to prevent the PQC from recurring.
 
Responsibilities:
  • Author, review, and approves Product Quality Compliant (PQC) investigations
  • Ensure proper intake, initiation, evaluation, and investigation of PQC(s), provides input to functional groups during evaluation, investigation, closure and implementation of associated CAPA's
  • Contributes to the development and continuous improvement of the PQC process across the Cell Therapy Operations
  • Collaborate with cross functional teams (i.e. Scheduling & Cell Logistics, Global Drug Safety, manufacturing sites, etc.) to ensure proper communication and collaboration for PQC(s)
  • Support and train cross functional groups with guidance on PQC process to ensure accurate reporting, investigation, root cause analysis and corrective actions
  • Perform routine and ad hoc Quality Systems metric reporting and analysis for the PQC(s) data
  • Prepare metrics and perform periodic trend analysis for PQC(s) in support of CTDO management review
  • Provide communication as to the status of PQC(s) deliverables to management, and stakeholders
  • Act as PQC Subject Matter Expert (SME) to support cross functional groups for PQC(s) intake, investigations, approval, and reporting
  • Support internal, external audits and regulatory inspections such as data gathering, PQC process support and/or other audit support functions as necessary
  • Support corporate requests for compliance and regulatory assessments
 
Qualifications:
  • Degree in biology, chemistry, engineering or other related field
  • 2+ year's relevant industry experience in a cGMP/FDA regulated environment, preferably
  • 2 years Quality experience with one or more years of experience within Quality Systems
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Paul Quibuyen
Christian.Quibuyen@eclaro.com
6466952942
Paul Quibuyen | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
 

Application Instructions

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