Quality Assurance Manager Resume Sarasota, FL - Hire IT People

SUMMARY

Quality Manager and patent holding MBA graduate actively seeking a role utilizing my technical and interpersonal strengths.
Experience encompasses quality, manufacturing, and process development in multiple industries.
Six years of engineering experience in manufacturing settings. Seven years of laboratory experience spanning incoming QC/QA, R&D, and analytical testing.
Working knowledge of ERP and LIMS systems and a lead auditor for the ISO 9001 quality system.
Applicability includes leading cross functional projects and post - baccalaureate education.

PROFESSIONAL EXPERIENCE

Confidential, Sarasota, FL

Quality Assurance Manager

Responsibilities:

Team lead on initiative to correct corporate SOP manual to comply with 21CFR Part 211.
Created site safety program to strengthen team competency on OSHA regulations.
Conducted IQ/OQ/PQ on new machinery and instrumentation.
Lead CAPA investigations to determine root cause of manufacturing related quality issues.
Revised raw material specifications for supplier quality using Six-Sigma methodology and led supplier audits.
Trained personnel on procedures, cGMP protocol, and site safety program to facilitate cGMP compliant manufacturing environment.
Managed and mentored team on critical to quality factors to increase product yield and improve product traceability.
Quality lead for FDA audit preparation team and quality representative for organization.

Confidential, Parlin, NJ

Manufacturing Engineer

Responsibilities:

Experienced in PSM and High Hazard Process Area for semiconductor manufacturing. Supervised 12 process technicians ensuring minimal downtime and operator error.
Team member for site Process Hazards Analysis group. Managed capital project work ensuring project completed key deliverables within time and budget.
A critical chemistry lead for colleagues during polymer synthesis reactions.
Business lead for air permit handling and annual hazardous reporting to NJDEP and EPA.
Monitor processes in manufacturing flow involving equipment, logic control, and automated instrumentation.
Ensure conforming product is manufactured for customers. Supervised all steps of production, from raw material selection, in process adjustments, and filtration schema.
Compounded experience leading PSSR, test trials, and MOC for process including scale up. Optimization using long term data to determine capability of manufacturing process.
Experienced in DOE, FMEA, and leading Kaizen and 5S initiatives.

Confidential, Parlin, NJ

Quality Engineer

Responsibilities:

Develop and facilitate FMEA's teams, develop Control Plans, and analyze SPC based on long term data packages.
Lead CAPA process and ensure compliance and effectiveness after implementation,
Investigate current process capability using Minitab and Excel statistical software.
Successful Completion of Ionic Content via ICP-OES and Film Thickness validation project for Six Sigma Green Belt certification.
Conducted ISO 9001:2015 lead audits on all functions of the business.
Assist and train technicians on laboratory instrumentation and methodology.
Conduct and lead projects on existing formulations as per customer requests. Prepare data packages for validation and gage capability of measurement systems.
Assure metrology standards are attained in the laboratory and cleanroom.
Generate customer C of A’s based on client specific results and specification range.
Calibrate and repair equipment to ensure uptime in laboratory and cleanroom

Confidential, Englishtown, NJ

Chemist I/II Co-authored Patent

Responsibilities:

Perform routine analytical testing of raw materials as per SOP or USP Methodology.
Validate client specific methodology and update SOP database as required.
Participated in laboratory safety training and hazardous chemical handling.
Coordinate preparation of documents and chain of custody for external sample analysis.
Assisted on larger projects and worked independently on sample requests from prospective clients. Interpreted feedback to best suit client needs.
Critiqued benchmark formulations to develop competitive product. Researched claims specification and applicable performance.
Supervised pilot batches from raw material selection to packaging.