Warehouse Receiving Document Control
Resume:
Dania Esposito
**********@*****.***
Highly motivated and energetic GMP Quality Assurance Professional with over 20 years’ experience in pharmaceutical manufacturing and packaging. Skilled in Process Validation and Document Control with an attention to detail. Ability to analyze current organizational and Quality systems with a record of designing and implementing innovative enhancements.
Detailed below are 20 years of service within the three divisions of a pharmaceutical manufacturing, packaging and distribution company, featuring a series of advancements through the organization as the systems I created were adopted, and growth of the company recommended my skills be applied to new projects. I am a fast-paced worker, universally valued for my reliability, dedication, and attention to detail, with a solid record as a committed team player where not the acknowledged team leader.
Professional Experience - 2015-Present
Ultra-Seal Corporation, Gardiner, New York
Quality Assurance Coordinator / Warehouse Receiving
Receipt of packaging components and bulk product (bottles, caps, film, displays, shippers; tablets, creams, ointments, etc.)
Maintenance of up-to-date Specification Sheets for outside vendors of bulk, and packaging components
Maintenance of original artwork PDF files / Artwork File Proof numbers
Collection of samples of all components for QA review
Disposition of components based on testing to specification
Match of components to job specification sheets and / or artwork
Scheduling of dock appointments for all incoming product
Updating of inventory spreadsheet
Generation of redundant inventory reports for archive and circulation
Maintenance of a secure Retain Area for various sample types
Other assigned duties and tasks as the needs and priorities of the company change
Forklift certified
Ultra-Seal Corporation, New Paltz, New York – 2008 to 2015
Quality Assurance Coordinator Packaging Division
Oversight over broad Quality Assurance functions involved in multi-line liquid, powder, ointment, and solid dose filling and packaging operations, with authority to initiate system improvements.
Receipt of all bulk product and packaging components.
Review and Approval of packaging artwork and film from contract customers.
Maintenance of up-to-date files with current artwork and film
Development of streamlined procedures for accurate and controlled receipt and disposition of customer artwork, matched to bulk released for packaging.
Initiation of Change Controls for batch record creation and revision.
Draft, review, and approve SOPs for Quality and Production, based on detailed firsthand experience or research.
Function as Quality Lead for packaging validation, IQ/OQ execution, other protocol documentation.
Oversight over Document Control with accurate administration of packaging documents prior to, during, and subsequent to packaging processes.
Schedule and conduct GMP training for Production, Quality Assurance and Sales personnel.
Maintain up-to-date SOP Index and GMP Training Matrix for Production and Quality personnel
UltraTab Laboratories, Highland, New York – 2000-2008
Senior Quality Assurance Inspector
Development and implementation of Quality Systems designed to meet GMP compliance goals within a young and growing organization manufacturing solid-dose, liquid, ointment, cream, powder drug and supplement products, with active role at head of the Shopfloor Quality Inspection group.
Overhaul and consolidation of Quality documents with creation of an electronic computer shared drive repository.
Generation of a universal SOP template, with alpha-numeric rubric for issuing document numbers.
Implementation of an electronic filing system for Master Batch Records for all products with formal control binders with change control and investigation links for compliance and process control.
Development and administration of an electronic Training Matrix, introducing cross-referenced training with links to SOP effective status, to create a comprehensive record of completed training to enhance GMP compliance.
Streamline of validation recordkeeping by creating and maintaining a hardcover protocol library for ease of presentation and an electronic index to issue protocol numbers and track validation product status
Ensure compliance of Quality Management Systems and GMP though inspections and in-process control audits of Production and Quality Assurance personnel.
Perform daily, monthly, annual calibration on Production and Quality measurement and testing equipment.
Additional Skills
Microsoft Office (Word, Excel, PowerPoint, Outlook)
Macola Accounting Software
Electronic System Administration
Education
A.A. Culinary Arts: Sullivan County Community College, State University of New York
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