QA Manager Resume Cary, NC - Hire IT People

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

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:

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: