Julia Vardy Blumenthal

About Julia Vardy Blumenthal

I am a skilled Quality Assurance professional with extensive experience in QMS; passionate about sustained product quality, continuous process improvements, regulatory compliance & excellence in customer service!BACKGROUND• Extensive Quality Systems (QMS) and Strategic Account Management (SQM / SRE) experience in the Biotech / Pharmaceutical Industry (25 years)- Disposable Wet Wipes Manufacturing - Filtration Technology: Filter Cartridge /Single-Use System; Vaccine & Solid Dose Manufacturing - ISO 9001 & cGMP Compliance; FDA interaction • Education & R&D experience in Chemistry & Biochemical Pharmacology (5 years)AREAS OF SPECIALIZATION • Exceptional QMS Management- Solid execution of the external Customer Complaint Investigation / Resolution process, consistently achieving drastic reductions in customer complaints & overall improvements in customer satisfaction, for 8 consecutive years- Expert in conducting Manuf. Deviation Investigations/ CAPAs /Data- driven Trend Analyses- Extensive experience in conducting Internal Audits; Document Control/SOPs; Batch record review (QA & QC) and product disposition; Validation Protocols; Personnel Training. • Ardent advocate of global harmonization of Quality Systems & continuous Quality Improvements.• Outstanding work ethics: 3 promotions & superior (\"exceeds expectations\") performance reviews at Pall Corp.• Successful Strategic Customer Acct Mgmt: effective/valuable Quality contributions to Global Supplier Quality Management (SQM) & Supplier Relationship Excellence (SRE) Programs, achieving improved supplier status.• Effective Personnel Mgmt: demonstrated as Sr Director of Quality Operations, by leading an exceptionally performing, cohesive and responsive Quality Team.

Experience

1. Senior Quality Advisor

   Premier Care Industries

   Jan 2021 — Present · NY, US

Education

• Brooklyn College

  BS, Chemistry

• Albert Einstein College of Medicine - Sue Golding Graduate Division

  Biochemical Pharmacology

Skills

• U.s. Food and Drug Administration (Fda)
• Glp
• Capa
• Corrective and Preventive Action (Capa)
• Lims
• Cleaning Validation
• Gxp
• Aseptic Processing
• Personnel Training
• 21 Cfr Part 11
• Qms
• Standard Operating Procedure (Sop)
• Good Laboratory Practice (Glp)
• Manufacturing Deviation Investigations
• Pharmaceutical Industry
• Sop
• Fda
• Validation
• Filter Manufacture
• Change Control
• Quality System
• Filtration Technology
• Customer Complaint Review / Investigation / Resolution Process Management
• Supplier Relationship Excellence
• Biotechnology
• Strategic Customer Account (Sam) Management
• Laboratory Information Management System (Lims)
• Quality Assurance
• Internal Audit
• Gmp
• Supplier Quality Management
• Trend Analysis