Quality Assurance Engineer

ANTHONY NICOLA, Ph.D.

**** ************ ****, ***** ******, New York 14510

607-***-**** E-Mail: abm02k@r.postjobfree.com

QUALITY SPECIALIST:

Validation, Engineering, Quality Assurance, Compliance

Quality Assurance specialist with extensive experience in validation

project management, pharmaceutical manufacturing, medical devices,

training, and regulatory compliance. Subject matter expert proficient in

team building, policy and procedure development, and risk management.

Combines expansive scientific background and instructional experience, with

a history of accomplishment, for innovative problem resolution. Reputation

for strong work ethic, approachability, and consistent commitment to

corporate success.

QUALIFICATIONS

Validation Master Planning cGMP (U.S. and International) Facility

Renovation

Facility and Cleanroom Certification Pharmaceutical Water Systems

Personnel Management

Process and Cleaning Validation Buildings / Facilities Validation Risk

Assessment

Laboratory / Production Equipment Site Master Files IQ / OQ / PQ

Computer System Validation Electronic Records / Signatures Medical

Devices

PROFESSIONAL EXPERIENCE

SYNTHES USA, Elmira, NY 2008-present

$3.5B global medical device company specializing in orthopedic instruments,

implants, and biomaterials.

Quality Engineer, Validation

Oversight of plant validation program, involving program development, to

ensure compliance with internal procedures and regulatory requirements.

Lead 20+ manufacturing engineers and quality engineers in process and

product validation. Generation of metrics to evaluate product

nonconformance rates plantwide. Management of process monitoring program.

Coordinate supplier quality assessments and supplier process validations.

Direct and oversee site validation master planning. Facilitate QA

department review of quality records, validation and testing protocols,

product quality plans, and FMEA documents.

Deficiencies in supplier quality and validation programs identified

early, allowing for corrective and preventive action plans to be

implemented, and product to be launched ahead of schedule.

Facilitated improvements in validation program such that planning at

early stages of new product development led to an improvement in the

overall time to market while maintaining quality and compliance.

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Quality Engineer, Validation (continued)

Nonconformance rates for problem areas were accurately identified,

resulting in a net decrease in total nonconformances.

Realized a 5-10% improvement in quality costs by identifiying well-

performing processes and standardizing the review and approval of

quality documents.

ASTELLAS PHARMA MANUFACTURING, INC., Grand Island, NY 2000-2008

$9B global pharmaceutical company providing a wide range of products in the

fields of urology, transplantation, cardiovascular, dermatology, and

infectious disease.

Progressed through multiple positions of increased responsibility,

including Validation Technician, Validation Scientist, and Senior

Validation Scientist

Development and refinement of plant validation program, demonstrating

excellence in generating policies, procedures, and Validation Master Plans.

Lead 3 validation specialists in all aspects of validation, including

processes, equipment, utilities, and cleaning validation. Primary

validation department contact for regulatory authority audits and

inspections. Management of the validation efforts for a facility

renovation including expansion of cleanroom space. Develop Site Master

Files for international markets. Conduct internal audits of company's

Quality System and Engineering Department, and supplier assessment audits

of various software and integration vendors. Design and implement

databases for validation department project and document tracking, as well

as departmental metrics.

Tracked and maintained facility renovation validation projects and

scheduling, resulting in project completion within tight timelines

(approx. 4 months).

Implemented a periodic monitoring and recertification program for

process, cleaning, and equipment validation.

Identified improvements to site quality system, contributing to

exemplary regulatory inspection record for the facility: the

manufacturing site has received zero FDA "483" notices through multiple

regulatory inspections.

Generation of Site Master Files supported the approval of drug products

in 8+ global markets.

Introduced methodology to optimize filling process for topical drug

products, resulting in a 5-10% increase in manufacturing capacity.

Integrated fully user-friendly database to generate continuous metrics,

improving the efficiency for tracking of validation projects and

department personnel training, and providing immediate validation

document retrieval during regulatory authority inspections.

Developed User and Functional Requirements Specifications to streamline

validation process for temperature-controlled environments and

equipment, which resulted in a release of fully compliant systems a

minimum of one week ahead of schedule.

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EDUCATION & CREDENTIALS

Ph.D., Analytical Chemistry

B.S., Chemistry

University of Pittsburgh, Pittsburgh, Pennsylvania

PROFESSIONAL TRAINING & DEVELOPMENT

Cleaning Validation Practices for Pharmaceutical Production (University of

Wisconsin)

Network Infrastructure Qualification & Systems Validation (Institute of

Validation Technology)

Cleaning Validation & Critical Cleaning Processes (Institute of Validation

Technology)

HVAC for Pharmaceutical Facilities (International Society for

Pharmaceutical Engineering)

Facility Qualification (Institute of Validation Technology)

5-S (Productivity Consulting, Inc.)

International Validation Week, 2007 (Institute of Validation Technology)

Geometric Dimensioning and Tolerancing (Synthes USA)

TECHNICAL SKILLS

Microsoft Office: Word, Excel, Powerpoint, Project, Access AS/400

Enterprise Minitab StatGraphics Pro-Intralink

iGrafx Flowcharter DocuSphere Content Manager

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