SUMMARY

• Agile, goal oriented, data driven, quality professional with a strong academic background in Cell & Molecular Biology with applications in Biotechnology and Bioinformatics.
• I am a skilled communicator that has served in various health care positions, supplementing graduate course work with field experience to exercise effective judgment and critical thinking.

TECHNICAL SKILLS

• Confidential Office 360, Google Chrome, Adobe Illustrator / Design
• Citrix Digital Workspace and Cloud Software
• EPIC - Electronic Health and Medical Records
• Tableau Worksheets - Data Analysis Visualization
• Oracle Database Software Enterprise Resource Planner
• Trackwise (Sparta Systems)
• Confidential Cognos Connection - Regulatory Submission Records
• EQMS / FDQM (Pilgrim) - EDM First Doc Quality Manufacturing
• SAP Enterprise Resource Planner
• FUSION ERP (Blue Software) - Label Management System
• LIMS - Laboratory Information Management System

PROFESSIONAL EXPERIENCE

Confidential

Responsibilities:

• For New Product Launches, coordinate with SME’s on design inputs.
• Project management/oversight of implementation.
• Build, implement and maintain Quality procedures for Labeling
• Progress artwork (sustaining or NPD) through Artwork Management system (EAMs, Shire AMS SAMs, Focus (Blue AMS)
• Artwork creation, update and maintenance.
• Identify gaps and ensure procedural alignment between Confidential AM and CMO AM.
• Ensure revision control, i.e., obsoletion of old artwork.
• P.O.s (Non-Inventory) related to typesetting/print vendor services and/or CMO art change fees that are not included in unit price of the product.
• Artwork Mockup - Create/revise art file based on Regulatory and P&E input.
• Communication of new art change to OPU and CMO.
• To CMO

  AM sends P/N request form directly to CMO

  AM sends change summary report to CMO

• To Confidential Team

  AM sends notification to planning/QA/ESL/P&E via change control “SME” or “Notification Only”

  AM attends weekly CMO meetings

  AM communicates with both teams

• Bar Codes - Apply pre-defined codes (from Regulatory) to art file (FPO) and confirm accuracy from CMO scanned report.
• Child Change control (Implementation). AM initiates and coordinates.
• Serialization - Apply already defined features onto art file.
• Tech Transfer - Process new art (same as New Product Launch)
• Project support & direct involvement in early stages
• Label change based on Local Office LOC Regulatory Requirements - Country RA
• Manage timing of revision changes.
• New Labeling Launch
• Pulling P&E support as needed to modify art structure.

Confidential

Labeling Specialist

Responsibilities:

• Interface & collaborate with Global R&D, Regulatory, Quality Assurance, Packaging Engineering, Trademarks, & Designers
• Execute submission / production labeling upon Ministry of Health (MOH) / Health Authority (HA) approval
• Interact with Country RA Regulatory Affairs and Global RA to implement artwork changes on specific product dossiers
• Production component part numbers, dynamic barcodes, Serialization, lines of code (LOT EXP MFD, 2 of 5, Laetus codes)
• Reasons for change: GTIN, Global Codes, Local Codes, Dynamic Barcodes, Indications, EU MDR, Graphics, Supplier
• Manage and route current base artwork for markup and review to pertinent stakeholders per change project
• Primary and Secondary packaging CP labels, Labels, Carton, Inserts (Instructions for use IFU / DFU Directions for use)
• Maintain global traceability thorough global codes for launch or revisions via serialization & global trade ID numbers
• Disposition of existing labeling components: Exhaust, FIFO, Destroy At Once, Destroy upon release of new lot
• Monitor changes in labeling requirements in the US and abroad and update submission or production accordingly
• Review promotional labeling and ensure that it applies with approved labeling.
• Monitor, evaluate and recommend improvements to labeling process, quality, systems tools and/or policies.
• Prioritizing projects & meeting revision / launch deadlines for all global labeling projects to completion
• Facilitate the review and approval process for all artwork and labeling from development through final proofs
• Evaluate content of labeling changes and determine appropriate reviewers, disposition of stock and implementation strategies
• Report project status in interdepartmental meetings.

Confidential, Thousand Oaks, CA

Responsibilities:

• Supply Chain BOM (Bill of Materials) Change Controls: Final Drug Product Artwork (FDP)
• Manage Customer Facing SKU Change Records and Revised Materials for Commercial FDP
• Bill of Materials (BOM) management and redlining - Artwork / SKU revision / New Alternative BOMs
• Manage the BOM effective date per Global and Regional Change Strategies
• Interface with site manufacturing and production - Puerto Rico AML (DS, Fill and Finish FDP, Packaging & Labelling)
• Open electronic Customer Facing SKU (Stock keeping unit) Change Records
• Change Control Impact Evaluation & Risk Assessments per ECN (Engineering change number)
• ERP / MRP Supply Chain Workflow Management: Purchase Order and ECN Engineering Change Notice
• Project Management Workflows: Open, Pre-implementation, Implementation, Post-Imp. and Closure
• Review Regulatory Filing Submissions, Change Reportability, and Product Distribution Constraints
• Analyze Local Label Changes, Initial Launches, Follow-up launches, Product Line Extensions
• Manage simple label changes to product lifecycle changes - Chemistry Manufacturing and Controls (CMC)
• Interface with Regulatory Affairs (RA) for Health Authority (HA) for Distribution Approvals / Constraints
• Assignment of stakeholders: QA, Regulatory Affairs, Supply Chain, Delivery Device & Package Engineering
• Artwork for Drawings, Dispensing Packs, Top Web (TWEB), Bottom Web (BTWEB), Inserts / Leaflets (PI / PIL), CCL
• Vials (VI), Auto-injector (AI), On-body Injector (OBI) Pre-filled syringe (PFS), Low-Volume Dose, Capsules
• Manage all impacted commercial SKUs stock keeping units and material part numbers

Confidential, South San Francisco, CA

Responsibilities:

• Managed assigned product lots to assure all disposition requirements are met within SAP standard lead times:
• Managed Confidential external lot disposition for final drug product (FPD) released for European distribution via Confidential .
• Review documents for activities as authorized and described by our clients policies, procedures and job descriptions.
• Ensure that established quality systems are defined, analyzed, measured, implemented and controlled for GMP use
• Maintain system elements and documentation to ensure the requirements of the Quality Agreement are fulfilled.
• Review and determine CAPA/Investigation/Change plans to ensure quality requirements are met prior to GMP processing.
• Review quality system documentation for compliance to regulatory filings and cGMP compliance.
• Provide client oversight of the CMO quality unit to facilitate initiation, assessment, review and closure of change records.
• Review executed CAPA/Investigation/Change records, assess trends and effectiveness including metrics and data review.
• Track lot disposition change restrictions required by the system and ensure required actions prior to clearance
• Interface with Quality Site mangers to communicate all open deviation and prospective CMO release timelines
• Review and approve key metric and specifications for external lot Disposition in SAP
• Execute and progress record in Track Wise according to approved timelines.

Confidential

Quality Specialist - Supplier Management & Audits

Foster City, CA

Responsibilities:

• GMP Compliance - Clinical & Commercial API / DS
• Solid Dose & Device API (Drug Substance), DP (Drug Product), Excipient Fillers (Diluent, Polyester Starches)
• Global Master Audit Schedule Coordinator: Internal and External Audits
• Data collation and Presentation of eQMR Executive Quality Management Review / Quarterly Audit Metrics
• GMP Certs. & Accreditations Repository (BPO): EIR / 483 / GMP Certs. / Marketing License / MFG Auth. / Self Certs.
• Clinical and Commercial Oral Solid Dosage Products - Manufacture, Testing, Packaging, Labeling, & Distribution
• CXO Suppliers: Patheon (TRO), Catalent (Germany), Life Technologies (NY)
• Business Process owner (BPO) - Audit Lifecycle Data Management (Trackwise) Module
• Risk-Based Audit Assignments: 3rd Party SQA Services for Tier 3 & 4 CXO’s
• Pre-Audit Meeting Coordinator / Key Stakeholders / Product Quality Agreements
• Interface with KAMS (Key Account Managers) across Gilead's internal and external network
• Remote Audit Questionnaires / Risk-Based Evaluations / Supplier Rating and Standardization of Supplier Tiers
• Commercial Products: Confidential, Confidential, Confidential, Confidential, Confidential, Confidential