Nichole Caparelli

Senior Director, Quality | Head of Quality (QA/QC) | CDMO | FDA Inspection Readiness | Site Leadership

Role
Senior Director, Quality at Quotient Sciences
Location
Philadelphia, PA, US
LinkedIn followers
500 followers
General Business & ManagementView LinkedIn profile

About Nichole Caparelli

I am a quality management professional with over 20 years experience in quality assurance and quality control in the pharmaceutical industry.

Experience

  1. Senior Director, Quality

    Quotient Sciences

    Apr 2024 — Present · Philadelphia, PA, US

    I currently lead Quality for a CDMO site, with QA,QC, contamination control and training under my organization, supporting ~60 employees, and reporting directly to the Site GM and Chief Compliance Officer. My role includes full ownership of the quality system, regulatory inspections, and cross-functional quality strategy.

Education

  • Moravian University

    B.S., Chemistry

    1997 — 2001

Skills

  • Standard Operating Procedure (Sop)
  • Lims
  • Quality Assurance
  • Quality Control
  • Gmp
  • Analytical Chemistry
  • Quality Auditing
  • Chemistry
  • Validation
  • 21 Cfr Part 11
  • Laboratory Information Management System (Lims)
  • Uv/Vis
  • Usp
  • Trackwise
  • Hplc
  • Uv
  • Pharmaceutical Industry
  • Sop
  • Fda
  • Tlc
  • Chromatography
  • Root Cause Analysis
  • Change Control

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Nichole Caparelli — Senior Director, Quality at Quotient Sciences in Philadelphia, PA, US | Unifers