QC Analytical Scientist

QC Analytical Scientist

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This position will work in the GMP compliant QC Laboratories to qualify and conduct chemistry-based assays that support quality control of bio-pharmaceutical products being developed and manufactured.  Supports analytical test method validation and transfer activities at and between external sites for qPCR and ddPCR

Roles

  • Independently applies scientific judgment and contribute to milestones related to specific projects.
  • Represents QC business processes and needs within the department and at cross functional forums.
  • Maintains cGMP compliance within their laboratories & generates, revises, and/or approves SOP or test methods.
  • Ensures that all work is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
  • Initiates and owns deviations, CAPAs and change controls within the electronic Quality Management System.
  • Supports regulatory inspections and audits

Requirements

  • Requires BS degree in Chemistry, Biology or other related scientific discipline.
  • Applied knowledge and in-depth understanding of GMP Quality Control systems
  • At least 5-7 years’ experience with relevant laboratory experience in a regulated manufacturing or QC laboratory environment.
  • It is preferred the candidate have analytical experience with PCR, SDS Page and USP Compendia methods.
  • Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
  • Completes tasks where judgment is required in resolving problems and recommendations.
  • Experience with electronic systems such as LIMS, Trackwise, etc., is an advantage.