QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / International Regulations Summary: A highly knowledgeable and analytical Quality Assurance Professional that has excellent attention to detail and strong analytical, trouble-shooting, and organizational skills. A cognizant associate that has developed an understanding of the boundaries required by confidentiality, the importance of adherence to regulatory bodies, and scientific/medical documentation requirements throughout 15-20 years in GxP regulated environments. This professional has additionally acquired a functional knowledge of clinical processes cumulated via experience in the pharmaceutical industry and a completed personal growth decision to acquire fundamental Clinical Trials knowledge via a Clinical Data Management Certificate.

Highlights:

• Quality
• Investigations
• Regulatory
• Writer
• Raleigh
• Data Review
• Biotech
• Test
• Atlas
• Automation
• Data Entry
• Documentation
• Manufacturing
• Protocol
• Quality Assurance