GMP Bioanalytical Specialist

4 days ago

Lexington, Kentucky, United States TalentCraft Full time
Bioassay and Virology Operations Lead

This role is a critical part of our Quality Control team, responsible for managing the daily operations of the QC Bioassay and Virology Testing team. Key responsibilities include overseeing cGMP processes such as in-process, lot release, stability, and raw material testing. The ideal candidate will have a strong background in laboratory management and cGMP QC testing.

Key Responsibilities:
  • Manage daily QC operations for cGMP routine and non-routine testing of in-process samples, drug substances, final products, virus banks, and cell banks.
  • Review and approve equipment validation protocols, ensuring all QC instrumentation remains validated and compliant.
  • Manage QC supplies, including critical reagents and controls.
  • Support method validation and facilitate analytical technology transfers in collaboration with QC Technical Services and QA.
  • Lead quality management systems such as Change Controls, Deviations, OOS, CAPA, and other essential processes.
  • Author or review detailed documentation including retest protocols, investigations, CMC regulatory sections, SOPs, and more.
  • Oversee data and KPI trending to maintain quality metrics.
  • Conduct risk assessments to support QC Operations and ensure regulatory compliance for both internal and external audits.
  • Drive continuous improvements in processes and procedures to enhance compliance and efficiency.
  • Represent QC at cross-departmental meetings and maintain strong relationships with key stakeholders.
  • Train and develop team members to meet business needs and career goals.

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