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Avid BioservicesPosted 2 weeks ago

Director, Quality Control Analytical Sciences and Technology

$163,000–$204,000 year

On-siteTustin, California, United States

Full TimeSenior LevelMedium

Job Summary

Provide strategic oversight of all GMP analytical methods throughout their operational lifecycle to ensure they remain fit-for-purpose, compliant, and aligned with product and business needs. Serve as the primary escalation point for complex OOS/OOT investigations, recurring invalid assays, and emerging method performance risks by leading root cause analyses and implementing sustainable corrective actions. Establish a proactive analytical monitoring program using data and statistical tools to detect emerging risks, while developing dashboards and communicating health metrics to QC leadership. Build and lead the AS&T team, partnering with QC Operations, Regulatory Affairs, and clients on analytical strategy and issue resolution. Occasional overnight travel may be required for seminars or client meetings.

Required Qualifications

  • B.S. in Chemistry, Biochemistry, or Biology or related field
  • Minimum of 10 years of industry experience in a QC or analytical laboratory
  • Experience with analytical testing and equipment
  • Experience writing reports/procedures/specifications
  • Knowledge of GMPs and regulatory audits
  • Knowledge of FDA guidelines
  • Knowledge of USP
  • Knowledge of EP
  • Knowledge of EU Annexes
  • Knowledge of ICH guidelines
  • Ability to work overtime and/or weekends when necessary
  • Full-time onsite position availability
  • Monday through Friday work schedule availability
  • Ability to lift objects up to 25 pounds
  • Essential visual acuity including close, distance, and color vision

Desired Qualifications

  • MS or higher degree

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