Genezen
Sr.Associate,QualityOperations
“Sr. Associate, Quality Operations at Genezen. Skills: Quality oversight, Documentation review, Regulatory compliance. Provide quality oversight to operations. Provide quality oversight to manufacturing”
Industry & Context.
Problem solvers; Root cause analysis
Criminal background check, Drug screen required
What They're Looking For.
Must Have
GMP, SOP and regulatory requirements compliance, cGMP, GDP, and Genezen policies compliance, Product manufactured, tested, and released in compliance with SOP’s, cGMP’s, FDA and EU requirements
What You'll Do.
Provide quality oversight to operations
Provide quality oversight to manufacturing
Provide quality oversight to quality control
Address product quality terms
Address conformance to regulations
Address conformance to Genezen quality policies
Address conformance to Genezen procedures
Perform assessments during operations
Ensure work compliance with GMP
Ensure work compliance with SOP
Ensure work compliance with regulatory requirements
Provide guidance to production employees
Foster understanding of SOPs
Foster understanding of GMPs
Foster understanding of process improvements
Review cleanroom documentation
Review supporting area documentation
Ensure documentation accuracy
Ensure documentation contemporaneous completion
Ensure batch records accuracy
Ensure logbooks accuracy
Ensure documentation compliance with cGMPs
Ensure documentation compliance with GDPs
Ensure documentation consistency with Genezen policies
Develop controlled documents for QA
Optimize controlled documents for QA
Review SOPs for functional areas
Approve SOPs for functional areas
Review controlled documents for functional areas
Approve controlled documents for functional areas
Review critical raw materials
Approve critical raw materials
Ensure products manufactured are produced
Ensure products manufactured are tested
Ensure products manufactured are released
Review quality control tests
Approve quality control tests
Review Certificates of Analysis
Approve Certificates of Analysis
Review Master Batch Records
Approve Master Batch Records
Review executed batch records
Approve executed batch records
Provide guidance on errors
Support departments on errors
Ensure error reduction
Assist in final disposition of master cell banks
Assist in final disposition of viral vector products
Provide site GMP training
Provide site GDP training
Initiate Root Cause Analysis for Quality Events
Perform Root Cause Analysis for Quality Events
Gather data for Quality Events
Perform interviews for Quality Events
Work cross-functionally to ensure Quality Events thoroughness
Work cross-functionally to ensure Quality Events accuracy
Drive Quality Events to closure
Review specifications for labels
Approve specifications for labels
Implement specifications for labels
Generate Media Fill Protocols
Review Media Fill Protocols
Approve Media Fill Protocols
Generate Media Fill summary reports
Review Media Fill summary reports
Approve Media Fill summary reports
Participate as Quality observer
Perform Quality Oversight for Manufacturing
Perform Quality Oversight for QC
Perform Quality Oversight for warehouse
Assist with Quality Oversight for Manufacturing
Assist with Quality Oversight for QC
Assist with Quality Oversight for warehouse
Review Stability Protocols
Approve Stability Protocols
Initiate Corrective and Preventative Actions
Review Corrective and Preventative Actions
Approve Corrective and Preventative Actions
Monitor CAPA effectiveness
Initiate Change Management activities
Review Change Management activities
Approve Change Management activities
Implement Change Management activities
Give guidance on use of quality systems
Lead site internal audits
Perform site internal audits
Support customer audits
Lead regulatory inspections
Support regulatory inspections
Collaborate cross-functionally to ensure product manufactured according to
Collaborate cross-functionally to ensure product complies with regulations
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Work with other functional areas
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