SUMMARY

• 10 years of applying passion for Quality - by-Design to Pharmaceutical data analysis, system migrations and software design.
• Promoting a vision of an intuitive MES system with a startup team transforming an internal Project Management tool into a user-friendly SaaS application by translating my industry experience and customer feedback into software requirements and development roadmaps.
• QA auditing of Confidential documentation, processes
• Designing, testing and validation of MES SaaS (Agile SCRUM)
• Creating webinars, training videos, user manuals, protocols, SOPs, OQ test scripts
• Analyzing compliance gaps, redundancies, migrating legacy data
• Process consulting/MES implementation - Electronic Master Manufacturing Records
• Dietary Supplement Confidential consulting
• QA auditing/disposition of parenteral Batch Production Records/COAs
• Investigating OOS deviations, writing of reports and associated CAPAs
• QC Microbiology testing, EM of aseptic manufacturing of pharmaceuticals, inspecting FG

TECHNICAL SKILLS

• cGMP 21 CFR 210 211 820 21 CFR part 11
• ISO 9001
• GAMP5
• Agile SCRUM
• Axosoft/OnTime
• Sharepoint
• InstantGMP
• Nautilus LIMS
• Trackwise
• Isotrain
• CALMAN
• RAM
• Jump
• EDMS
• DBO
• Documentum eDocs eStorr
• Lotus Notes
• Word
• PowerPoint
• Excel
• Outlook
• Camtasia. Business Catalyst
• Climet
• Met One
• SAS
• Bio-strip
• Bio-spin Air
• Anatel desiccator manual/automated pipettes
• Ohaus mettler toledo.

PROFESSIONAL EXPERIENCE

Confidential, Cary, NC

QA Manager

Responsibilities:

• Designing and recommending system requirements for UI
• Coordinate improvements for Materials, Inventory, Requisition, MPR, BPR, Reports
• QA/cGMP software/system testing, reporting defects, mapping solutions
• QA Validation documentation (SDLC/CSVP) and management of execution
• InstantGMP Process consulting and implementation of electronic MMRs/MPRs
• Confidential 101/Quality training and advanced technical support for MES software
• Controlling internal and for-sale Policies and SOPs
• Creating training videos and User Manuals
• Creating Webinars "Electronic Batch Records: Benefits and Implementation Planning"
• Facilitating and managing customer relations, feedback and troubleshooting SaaS
• Demonstrating InstantGMP software features remotely for potential customers.
• Editing of marketing articles/brochures
• QADC/Holding room operations for Confidential, Inc. Clients

Confidential, RTP, NC

Quality Assurance Auditor

Responsibilities:

• Auditing data for compliance, Phase auditing
• Large scale scanning, electronic archiving and paper filing of controlled documents
• Creating of PowerPoint presentations for ISO/GLP training

Confidential, Morrisville, NC

Quality Assurance Specialist

Responsibilities:

• Assuring control, logging and reconciliation of holding room documents
• Compliance Auditing of BPRs, production and lab logbooks
• Routing all internal customer requests for protocols, SOPs, logbooks, etc.
• Quality Assurance of batch issuance
• Logging and arrangement of shipment of controlled documents to off-site locale.

Confidential, RTP, NC

Quality Control Analyst

Responsibilities:

• Environmental Monitoring of clean rooms and sterility suite, bioburden testing
• Auditing of large scale sample collection frequency data for compliance, deviations
• HEPA AHU shutdown studies to re-evaluate limits and update SOPs

Confidential, Clayton, NC

Quality Assurance Auditor

Responsibilities:

• Auditing/disposition of batch records for Confidential /Health Canada/SOP compliance/release
• Reviewing associated weigh tickets, COAs, cleaning tags, component prep, biological and chemical testing, inspection, and shipping and restriction paperwork
• Inspecting/dispositioning of finished product, labels, inserts; paperwork/data entry

Confidential, Raleigh, NC

Quality Control Analyst

Responsibilities:

• Dynamic and routine EM of aseptic compounding and fill areas, personnel
• Collecting water samples, reading plates, inspecting product (syringe)