778 Pharmaceutical Project Management jobs in Spring Hope, NC
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Quality Assurance Specialist (Two openings)

Johnson and Johnson

Wilson, NC

Bachelor's Degree

Within 15 miles of Wilson, NC

~ 30 min Onsite

  • Proficiency in technical writing for validation and quality documents.
  • Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides.
  • Strong understanding of risk-based approaches to commissioning and qualification/validation.
  • Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles.
  • A minimum of a Bachelor's or equivalent University degree is required with a focus in scientific or engineering discipline preferred.
  • Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators - as well as Process Equipment - Bioreactors, UF/DF, centrifuge, Chromatography systems.
  • Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation.
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