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
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
Senior Director, Quality
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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