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Qa Manager Resume

Cary, NC

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)

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