Lori Semeraro
Quality Compliance and Auditing Professional
- Role
- Senior Director Quality Assurance Gxp at PTC Therapeutics, Inc.
- Location
- Tarrytown, NY, US
- LinkedIn followers
- 500 followers
Information TechnologyView LinkedIn profile
About Lori Semeraro
Professional with extensive quality assurance and auditing experience in GCP, GLP, GMP and PV. An effective team player and independent contributor with clinical operations and compliance experience.
Experience
Senior Director Quality Assurance Gxp
Sep 2019 — Present · New York, NY, US
Education
Temple University
Master of Science (MS), School of Pharmacy Quality Assurance Regulatory Affairs Program
2013
Boston University
Bachelors, Biology
Skills
- Change Control
- Gxp
- Quality Auditing
- Clinical Trials
- Standard Operating Procedure (Sop)
- Quality Assurance
- Clinical
- Regulatory Affairs
- Cleaning Validation
- Good Laboratory Practice (Glp)
- Trackwise
- Glp
- Inspection
- Gcp
- Biopharmaceuticals
- Clinical Development
- Qc
- Quality System
- Quality Systems
- Ich-Gcp
- Training
- Microbiology
- Pharmaceutical Industry
- Sop
- Fda
- Validation
- Clinical Monitoring
- Training Skills
- 21 Cfr Part 11
- R&D
- Regulatory Submissions
- Supervisory
- Bpf
- Pharmacovigilance
- Quality Control
- Gmp
- Pharmaceuticals
- Regulatory Requirements
- Biotechnology
- Clinical Research
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