Genentech-posted 9 months ago
$73,500 - $136,500/Yr
Full-time • Mid Level
Philadelphia, PA
Chemical Manufacturing

The position will be responsible for sample and data management within the QC laboratories. Specifically, the position will perform and coordinate sample receipt/inspection/login/distribution/disposal/shipping, control the chain of custody, and support internal and external testing. This position will be responsible for monitoring and tracking sample status through the sample lifecycle, tracking QC data records from initiation to QC reconciliation, ensure target due dates are met, and provide management updates on project timelines/status. This position will also be the point of contact for cross building support and associated processes. In addition, the position will drive improving the current process and revising SOPs accordingly, lead in deviation investigations, facilitate training, perform laboratory maintenance, perform routine laboratory testing, support equipment maintenance and trend metrics as needed. This role will also provide oversight of the daily activities ongoing in the sample management area.

  • Sample management
  • Chain of custody control
  • Sample shipping management
  • Controlled document print, distribution, and reconciliation
  • Cross-building SDM support and oversight
  • Maintain regulatory retain and characterization inventories and inspections
  • Monitoring and tracking sample lifecycles
  • Monitoring and tracking data lifecycles
  • SME for SDM LIMS GMP document generation and revision
  • Leading Sample Management deviations and investigations
  • Regulatory and internal audit support
  • Operational data trending for process improvement
  • Gathering data required for metrics for Sample Management
  • Supporting routine laboratory testing
  • Bachelor's degree in biology, chemistry, or related discipline preferred
  • 3 - 6 years of biopharmaceutical working experience, with at least 2 years GMP experience
  • Experience with QC sample management and GMP document revision
  • Experience with using LIMS to manage samples
  • Experience in technical writing
  • Experience in regulatory audits as a plus
  • Experience with performing testing (e.g. qPCR, ELISA, HPLC, etc.) as a plus
  • Experience with reviewing GMP and non-GMP data as a plus
  • Lean six sigma training as a plus
  • Knowledge of common QC tests for vector-based product as a plus
  • Ability to review and provide feedback on daily operations
  • Ability to support as SME in regulatory and internal audits
  • Ability to take ownership to a process and drive the improvement, evaluate impact to the current process (including quantifying improvement), and report out clearly to key stakeholders
  • Motivated to assume ownership of protocols, experiments, and continuous improvement projects
  • Good understanding and application of principles, concepts, practices, standards of GMP requirement
  • Discretionary annual bonus based on individual and Company performance
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