SUMMARY

• me has a Quality Assurance background (various areas of QA) wif experience managing and overseeing QA processes in a pharmaceutical regulated environment.
• Produce statistical documentation and communicate wif senior - level managers regarding Quality Assurance/Training issues.
• Provide supervision and training to QA group members. Sustain quality and compliance levels.

TECHNICAL SKILLS

• Policy/Procedure Development
• Change Control and Global Change Control
• Microbiology Operations
• Trackwise User for CAPA, Investigations and Change Control
• Documentation
• Validations (computer and manufacturing)
• Sharepoint
• MIDAS
• QUMAS Check-in and Release panel
• Training Database System Administrator: MyLearning, Eduneering, TM2000
• GMP Training
• Process Improvements
• Audit
• Global Specification System (GSS)
• Metrics

PROFESSIONAL EXPERIENCE

Confidential, Edison, NJ

Quality Assurance Records, Quality Coordinator

Responsibilities:

• Review Device History Records (DHR) and release products wif teh Enterprise Resource Planning System (ERP).
• me currently facilitate resolutions for any discrepancies in DHR records before teh product can be released.
• Provides data/metrics related to accuracy, completeness and cycle times for records being reviewed.
• Identify areas in need of improvement regarding accuracy, completeness and cycle times.

Confidential, Summit, NJ

Research Commercialization Quality, Quality Reviewer II

Responsibilities:

• Perform quality review of all Standard Operating and Laboratory procedure revisions.
• Perform audits on various functional areas related to Research Commercialization Quality, such as, laboratories, manufacturing, training, etc.
• Assisted in Creating Quality review, audit and training metrics on a monthly and quarterly basis.
• Document Liaison for teh management and archiving of GMP documents.
• Used teh following management tools; MIDAS, Mylearning, Sharepoint, Gap Analysis Tracking system and eDiscovery and Records Management system.

Confidential, Morris Plains, NJ

Quality Assurance, Senior QA Analyst

Responsibilities:

• Review and revise global raw material specifications.
• Mentor Quality Technicians on teh GMPs of reviewing and updating specifications.

Confidential, Monmouth Junction, NJ

Quality Assurance, Senior QA Specialist

Responsibilities:

• Create and maintain Raw, Active and Packaging Materials program
• Maintain, update and oversee teh Training program.
• Perform and review investigations and CAPA.

Confidential, Summit, NJ

Documentation Management Specialist

Responsibilities:

• Create and revise Production and Raw Material monographs for various international market sites.
• Create and revise International Analytical and Manufacturing Procedures.
• Interact wif sites internationally to clarify/gather analytical/manufacturing information.
• Initiate and track changes using teh Trackwise software database.

Confidential, East Hanover, NJ

Contractor - GMP Training

Responsibilities:

• Performed SOP and technical training for laboratory personnel
• Provided GMP training covering areas such as Change Control, CAPA, Investigations and Audits

Confidential, Elizabeth, NJ

QA Supervisor

Responsibilities:

• Assisted in creating and maintaining Confidential ’ new employee orientation training program.
• Attended Train teh Trainer seminar.
• Assisted wif and created customized reports wif TM2000 designer for Confidential ’ training manager database (me.e. Training gap analysis, Training logs).
• Created and revised task qualification checklists for Manufacturing Operations and Quality Control to ensure dat only qualified employees are performing tasks assigned.
• Scheduled and performed training for SOPs, GMP and Safety issues and ensured dat training complied wif regulatory and company polices and procedures.
• Member of teh Training Steering Committee.

Confidential, Fairfield, NJ

QA Manager

Responsibilities:

• Managed and supervised six individuals in teh Quality Assurance Department.
• Scheduled workload for Quality Assurance department on a daily and weekly basis.
• Reviewed and approved protocols, SOPs, validations, test scripts and reports.
• Updated and maintained Master Schedule of GLP Studies.
• Updated and maintained companies Quality Manual.
• Hosted and successfully attained ISO guide 17025 certification for testing laboratories.
• Scheduled and performed internal audits of GLP studies and internal quality systems, and external audits of vendors and suppliers to ensure compliance to GMP and GLP regulations.
• Hosted FDA regulatory, ISO and sponsor /customer audits.
• Maintained and performed GMP/GLP training and training records.
• Scheduled and maintained calibration and calibration log books of various testing equipment.

Confidential, Wayne, NJ

Senior Microbiologist

Responsibilities:

• Performed sterility, release, stability, Bioburden, environmental and USP particulate matter testing.
• Performed standard microbiological tests on raw materials and finished products.
• System Administrator for teh Vitek (bioMerieux) Identification System.
• Performed microbial identification using teh bioMerieux API and Vitek Identification systems.
• Develop test methods, including validation of methods according to cGMPs.
• Authored and revised Standard Operating Procedures (SOPs), protocols and Monograph’s.
• Trained laboratory personnel on cGMPs and SOPs.

Confidential

Chemist Technician

Responsibilities:

• Performed chemistry and metals analysis according to EPA Standard Methods.
• Operated GC/MS for volatile organic analysis.
• Started Microbiology program for EPA studies.