QA Senior Specialist (Raw Material Laboratory Compliance) | ClinLab Staffing
  • Pre-clinical/Life Sciences
  • Morrisville, NC
  • Applications have closed

Specific Responsibilities:

  • Performs raw material testing, as assigned.
  • Reviews analytical data associated with raw material testing, including results from third party contract laboratories and method qualification / validation protocols, ensuring compliance to specifications / acceptance criteria, for testing not directly performed.
  • Reviews raw material item specifications for testing requirements and sampling plans.
  • Evaluates new raw materials for testing determination with compliance to master plan, compendia and ICH requirements.
  • Provides Quality assessment for deviations, laboratory OOS investigations and change controls related to method and analytical instrumentation, for GMP and technical compliance, for testing not directly performed.
  • Participates on project teams and collaborates throughout the project lifecycle ensuring analytical data compliance.
  • Serves as contact for contract laboratories, QC and Analytical PD for raw material issues.
  • Provides raw material data metrics.
  • Revises and reviews master plans, SOPs, work instructions and training course plans for analytical instrument operation, raw material test methods, ensuring alignment with qualification documentation.
  • Serves as SME during audits for raw material issues, as needed.
  • Other duties as assigned.

Job Requirements

  • BS/BA and 4+ years of raw material laboratory experience