Quality Assurance

KELLEY SCOZZAFAVA

*** *** ******** ****, *********, NY 13460 518-***-**** *******@*****.***

QUALITY ASSURANCE MANAGEMENT PHARMACEUTICAL INDUSTRY

Quality-focused, customer-centric professional with continual success in pharmaceutical industry. Involved in streamlining processes through implementation of quality system improvements. Adept at auditing services, complaint handling, and resolving risks to ensure effective quality control. Innovative thinker who facilitates stringent product standards while effectively communicating with cross-functional teams. Providing close collaboration for product transfers and materials sourcing for compliance and consistency while ensuring no delays in projects. Key areas of expertise are:

Quality Assurance

Opportunity Analysis

Compliance Requirement

Procurement Management

Portfolio Analysis

Team Leadership

Strategic Planning & Implementation

PACE and Supply Market Analysis

Client/Vendor Management

Risk Mitigations & Adjustments

Product Documentation

Time Prioritization

Technical Competencies

SAP SAP CAPA SAP - Supplier Management System QUMAS Microsoft Word & Excel Visio Adobe Nitro

PROFESSIONAL EXPERIENCE

Norwich Pharmaceuticals Norwich, NY 13815

SR. QUALITY SYSTEM SPECIALIST – SUPPLIER QUALITY 2014 – Present

Oversees the quality assurance system for Supplier Quality. Evaluating each supplier (including calibrations services, labs, API providers, 3rd party CMOs and CPOs, inactive ingredients, pack components, labeling, and computer systems) through remote/paper and onsite audits. Directs the required audit schedule, supplier complaint processes, and information within the company while coordinating with other sites throughout the corporation.

Transitioned the supplier complaint system from a paper system to electronic-based platform.

Spearheaded a Kaizen event revamping the complaint system and consequently refining the overall process.

Effectively implements all change management related processes including maintenance of the Change Control and SCL systems and new owners training.

Enterprise Impact:

Streamlined supplier quality system by providing inputs for system enhancements and implementing computerized reports. Provided better tracking methods to identify and resolve issues; closing the gaps, and improving supplier services.

Successfully documented over 100 complaints in the first year of tenure, escalated from the ten recorded complaints in the previous year; transformed services to higher quality standards which increased production efficiency and decreased product complaints.

Efficiently drove leadership initiatives after headcount reduction in 2014 within the facility by implementing new computer systems, training employees on change control, supplier complaints, and auditing to increasing standards.

SR. SYSTEM ADMINISTRATOR, QUALITY STANDARDS – PRODUCTION DOCUMENTATION 2012 – 2014

Administered the manufacturing and packaging document transactions including master records, master specification (raw and packaging components), issuing records, creation/approval of shipper container labels, and change control.

Developed and launched new electronic Change Control System (QUMAS) which included training of all employees within facility and other facility locations in US.

Created and refined system reports for Auditing, Supplier Complaints, and Change Control together with IT system owners improving standards for reporting documentation.

Enterprise Impact:

Launched electronic systems making information available to proper audiences, saving time and easier tracking process; leveraging accountability of assignments within the system.

Pfizer, Inc. Rouses Point, NY

SUPPLY BASE MANAGER 2009 – 2012

Managed manufactured/packaged pharmaceutical products to support processes with several groups handling issues with raw materials or packaging components, buying maintenance items daily, and spearheading the resolution process of discrepant materials. Acted as Subject Matter Expert (SME) for the facility while creating, changing, and maintaining SAP data for materials.

Collaborated with development groups to initiate new products providing supply channels and pricing, and deliberated any changes at Material Review ensuring change awareness and impact mitigation to all employees.

Defined strategic techniques on change management to develop risk mitigation process on potential issues, creating good connections outside the facility and settling great rapport with other employees.

Worked with team to implement a new SAP system with streamlined efficiencies for client.

Enterprise Impact:

Contributed $1.5 million budget reduction in the first year through prompt identification and implementation of processes within Waste Reduction & Procurement Opportunities team increasing efficient resource utilization, improving vendor management, and identifying cost-effective and environmentally friendly waste options.

Successfully filled a gap as Supply Base Manager created from buyout and restructuring under new company

SUPERVISOR PRODUCTION SCHEDULING/BUYING 2006 – 2009

Supervised the raw materials and packaging components to ensure they were available to support production schedule while identifying new buyers and providing training. Monitored and controlled changes in SAP MRP and developed appropriate adjustment to the delivery schedule to adhere to JIT principles.

Effectively negotiated with current and alternate suppliers in controlling production and identifying issues to meet production calendar.

Enterprise Impact:

Incorporated strategic implementation in manufacturing and packaging sections to provide substantial work efficiency optimizing total cost, inventory levels, and schedule completion.

Successfully supervised the buying for operations avoiding outages, keeping production in-line with scheduled deliverables, and increasing employee accountability.

Provided support to the planning groups as material issues arise like the Japan tsunami which impacted the hypromellose market. Negotiated with current and alternate suppliers to ensure enough material was available at the right times sufficiently meeting production schedule and continuous delivery of materials.

EARLIER CAREER EXPERIENCE

Label Room Supervisor Pfizer, Inc., Rouses Point, NY 2005 – 2006

Sterile Process Technician Wyeth Pharmaceuticals, Rouses Point, NY 1992 – 2001

EDUCATION

Criminal Justice, In Progress

Empire State University Of New York, Plattsburgh, NY

AA, Criminal Justice

Clinton Community College, Plattsburgh, NY, 1990

TRAININGS & PROFESSIONAL DEVELOPMENT

Wyeth White Belt Training

Wyeth Yellow Belt Training

Lean Office Training – Six Sigma

Frontline Leadership Development Program

Norwich Approved Auditor

American Society for Quality Certification

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