Specialist, Quality Control - Raw Materials

Novartis UK

Durham, NC, US
Base: $85,400.00 - $158,600.00; bonus/equity: perf...
Onsite
Cgmp release and characterization testing
Chromatography (hplc, uplc)
Compendial assays
Assists and supports the organization with compliance and ongoing preparation, testing and monitoring conformance to established quality processes and standards for manufacturing and production

Job Summary

  • Assists and supports the organization with compliance and ongoing preparation, testing and monitoring conformance to established quality processes and standards for manufacturing and production.
  • Execute routine and non-routine analysis for cGMP release and characterization testing using techniques including but not limited to chromatography (HPLC, UPLC), AUC, SEC, compendial assays (pH, Conductivity, Osmolality), electrophoresis (CE, Western Blot) and assist with data review.
  • Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.

Matching Summary

Assists and supports the organization with compliance and ongoing preparation, testing and monitoring conformance to established quality processes and standards for manufacturing and production.

Salary

Base: $85,400.00 - $158,600.00; Bonus/Equity: Performance-based cash incentive and potential annual equity awards; Benefits: Comprehensive benefits package including health, life, disability, 401(k) with match, generous time off

Skills & Requirements

Must-have

  • cGMP release and characterization testing
  • chromatography (HPLC, UPLC)
  • compendial assays
  • method verifications/transfers
  • investigation of non-conforming results
  • trend analysis of data

Nice-to-have

  • strong technical writing experience
  • previous investigation experience
  • works on problems of moderate scope
  • self-motivated and detail-oriented

Key Requirements

  • Bachelor's degree in scientific disciplines
  • 5 years’ experience in GMP environment
  • 4 years’ at GTx

Work Rights

Not specified

Tailored Resume

Cover Letter