Technical/Quality Specialist

Quality Driven Professional

PROFESSIONAL PROFILE

Accomplished professional with a proven ability in the fields of Specialty Chemicals, Food Science, Pharmaceuticals Medical Device and Biopharmaceuticals; providing technical expertise in areas of Analytical Research and Development, Quality Control, Technical Services, Quality Assurance, Engineering, Production, Product Stability and Regulatory Affairs. Familiar with GDP, GLP, cGMP, ICH, ISO and FDA guidelines and strong understanding of Document and Change Control processes. Diverse, energetic team player, able to manage multiple tasks while achieving prioritized goals, with exceptional ability to interact, influence and negotiate effectively with in-house departments and sister sites.

AREAS OF EXPERTISE

Provides strategic, expedient and efficient preparation of client submission deliverables and dossier that meet

current local, regional and ICH regulatory and technical requirements.

Strong working knowledge of FDA QSR Regulations and Guidelines, 21 CFR 11, Medical Device Directives

(MDD), harmonized standards, ISO 13485, and related quality standards.

Exceptional understanding of industry standard Systems/Software Development Lifecycle (SDLC) practices.

Eleven (11) years’ experience conducting raw material, in-process, finished product and shelf-life testing.

Over 10 years’ experience performing Technical Writing in the Pharmaceuticals and Medical Device industry.

Tremendous ability to prioritize/schedule activities to meet department’s goals and objectives.

Adequate experience coordinating a commercial and non-commercial Product Stability Program.

As Safety Officer, excellent knowledge of safety and health standards in accordance with OSHA guidelines.

Experience with CAPA, Investigations, and deviations.

ACCOMPLISHMENTS

Trained Quality Control Lab personnel on the LabWare Laboratory Information Management System (LIMS).

Development of all associated documents including qualification testing, test plans and User Acceptance Tests

and protocols for GAMP-based validation of quality computer systems.

Initiated Protocol with Summary Report for the Analytical Method Transfer between R&D and Quality laboratories.

Successful coordination of the ANDA Product Review Project to support Regulatory Affairs compliance.

Developed the documentation template and coordinated the successful Technology Transfer of products.

Coordinated the Stability Transfer Project involving the transfer of stability samples and documentation.

Manages, reviews and approves key documentation related to the implementation of QMS systems.

PROFESSIONAL EXPERIENCE

Dec 2017 – Feb 2018 The Nature’s Bounty Co., Sr Technical Writer

Pharmaceuticals Industry

Deerfield Beach, Florida

Consultant hired through the Bioteknica Group to perform short term assignment for Packaging Dept. project.

Develop setup, operating, troubleshooting and cleaning procedures for all Packaging line equipment.

Interface with Subject Matter Experts (SME) and Quality Management to expedite review and document approval.

Review current department processes to identify gaps and recommend quality improvement measures.

Exercises judgement within defined procedures and practices to determine appropriate action.

Evaluates the project needs in relationship to the overall project timelines, quality and delivery.

Aug 2017 – Oct 2017 Pharmaceutical Product Development (PPD) LLC, Regulatory Publishing Specialist

Pharmaceuticals Industry

Wilmington, North Carolina

Consultant hired through the Solomon Page Group to perform short term remote assignment for PPD project.

Assists in preparing electronic document outputs that meet requirements for regulatory publishing to include

documents that work with sponsor and/or regulatory agency software programs meeting consistency and security issues.

Ensures that all final electronic deliverables meet current regulatory electronic document requirements and guidance.

Assists with developing and implementing project-specific processes for sponsors and unique technology requirements and may act as the PPD liaison for electronic submissions with the sponsor.

Exercises judgement within defined procedures and practices to determine appropriate action.

Evaluates the publishing needs in relationship to the overall project timelines, quality and delivery.

April 2017 – July 2017 ADB Automation and Validation Inc., Quality Management System (QMS) Specialist

Medical Device, Biopharmaceutical Industries

Hialeah, Florida

Develops the necessary SOPs and processes according to ISO 13485 and related quality standards for

the successful implementation and support of Quality Management Systems (QMS).

Supports new QMS Systems and enhancements dictated by the business needs or regulatory requirement.

Evaluates and determines appropriate test methods to support QMS System changes and configurations.

Serves as Document Management and Change Control System Manager and Administrator for the electronic system.

Manages, reviews and approves key documentation related to the implementation of QMS systems.

Maintain, review and update all QMS System procedures related to the process for continuous improvement.

Develop and conduct QMS System Training for new employees and ongoing training for existing users.

June 2016 – Mar 2017 Xerox State & Local Solutions, Inc., Remote Sr Technical Writer

Transportation Technology Services

Germantown, Maryland

Consultant hired through Willis Group to perform long term remote assignment for Xerox Corporation project.

Quality Assurance team member responsible for QA review of the Florida Centralized Customer Service System.

Interface with Xerox Subject Matter Experts (SME) and Document Management (DM) to expedite review and document approval.

Review design documents for compliance, technical accuracy and quality of presentation prior to final submission.

Generate a scoring document (Document Quality Measure) upon review to be utilized for quality rating and metrics.

Review/update design documents in response to Xerox SME and DM feedback and comments.

June 2010 - May 2016 ADB Automation and Validation, Sr Technical Writer

Medical Device, Biopharmaceutical Industries

Hialeah, Florida

Consultant responsible for creation of technical documentation for Quality Management Systems.

Author technical documentation in accordance with Systems Development Life Cycle (SDLC) phases, Life Science manufacturing and systems regulations (21 CFR Part 11, GxP etc.).

Role as author in order to write technical documentation for software systems in SharePoint 2010 environment.

Role as Reviewer in order to review validated documentation for software systems SharePoint 2010 environment

Role as Tester in order to execute IQ/OQ/PQ for software quality systems.

Acquires user input for work instructions by observing methods and interviewing Subject Matter Experts.

Utilized image capturing tools (e.g. SnagIt, Snipping Tool) in design and development of process and user manuals

Utilized PowerPoint to conduct project kickoff meetings and conduct SOP and User Manual training.

Responsible for working with project teams and development teams to create clear and precise user documentation and training materials.

Lead Technical Writer responsible for a variety of project documentation deliverables for the following clients:

oMedtronic/HeartWare International, Inc. – Miami Lakes, FL

oFacet Technologies – Kennesaw, GA

oLifeline Sciences –Farmington Hills, MI

oMitralign, Inc. – Boston, MA

May 2010-June 2010 Biotest Pharmaceuticals Corp, Technical Writer II

Biopharmaceutical Company

Boca Raton, Florida

Prepare/revise manufacturing batch records, work instructions, forms and associated SOPs for department.

Responsible for conversion of key manufacturing documents into macro based template format.

Working knowledge and experience with Electronic Documentation Management Systems (EDMS).

Responsible for training Manufacturing Technicians on macro based template format usage.

Acquires user input for work instructions by observing methods and interviewing Subject Matter Experts.

Creation of technical documentation for end user and administrator/maintenance technician

Feb 2008-Dec 2009 TEVA Pharmaceuticals USA, Technical Writer II

Generic Drug Manufacturer

Doral, Florida

Author/revise SOPs, protocols, procedure manuals, technical reports and product specifications for QC Lab.

Initiate/review Change Orders for completeness and accuracy relative to Change Control process.

Working knowledge and experience with Electronic Documentation Management Systems (EDMS).

Lead Technical Writer responsible for the periodic assessment of the USP and authoring crossover studies.

Perform LIMS system administration for the management of methods and product specifications.

March 2006-Jan 2008 MicroDose Therapeutics, Inc., (now TEVA) Technical Writer I

Medical Device Company

Monmouth Junction, New Jersey

Author SOPs, study designs, protocols, test procedures, technical reports, marketing publications and component

specifications.

Assess the compliance of Analytical R&D, Engineering and Quality Assurance versus SOPs and test procedures.

Interpret and address redlines or markups to all departments.

Review Engineering Change Orders for compliance and accuracy regarding documents and drawings.

Perform notebook review to verify technical content and data integrity of studies prior to sending to clients.

Acquires user input for work instructions by observing methods and interviewing Subject Matter Experts.

Utilized PowerPoint to conduct SOP and procedure training for Analytical R&D, Engineering and Quality Assurance

Utilized Adobe FrameMaker to publish Analytical R&D and Engineering user manuals.

Utilized image capturing tools (e.g. SnagIt, Snipping Tool) in design and development of process and user manuals

April 2005–Oct 2005 Purdue Pharma, L.P., Stability Scientist I

Generic Drug Manufacturer

Totowa, New Jersey

Associate hired through On Assignment-Lab Support to perform a 6-month assignment at P.F. Laboratories, Inc.

Develop, configure and manage stability specifications and test methods using Labware LIMS in Citrix

environment.

Responsible for entering real time and historical stability data into LabWare LIMS and Microsoft Excel.

Creates and approves Stability Protocols in LIMS for the initiation of accelerated and long-term stability studies.

May 2002–Sept 2004 Watson Pharmaceuticals, Inc., Stability Specialist

Generic Drug Manufacturer

Miami Lakes, Florida

Responsible for co-managing the Watson-Miami commercial and non-commercial Product Stability Program.

Develop, configure and manage stability specifications and test methods using LIMS: Stability System II.

Generates and monitors long term and accelerated stability studies using LIMS: Stability System II.

Evaluates stability test data, identifies and addresses OOS and OOT stability results accordingly.

May 2000–May 2002 Documentation Specialist

Write all test stage methods with specifications, SOPs, protocols and summary reports for R&D and QC products.

Cross-review documents to ensure quality of stand-alone documents and inter-relation to other SOPs and

policies.

Author Cleaning Validation Reports and Protocols to support the cGMP Cleaning Validation Project.

Promotion to position of Stability Specialist based on job performance and commitment to quality.

Oct 1998–May 2000 Quality Control Chemist

Preparation of standardized mobile phase and buffer solution for HPLC and dissolution testing.

Coordinate incoming samples for raw material, in-process, finished product, stability and validation testing.

Write all test stage methods, SOPs, protocols and summary reports for marketed and R&D products.

Selected as Technical Advisor for the Quality Improvement Program-Documentation Team.

Promotion to position of Documentation Specialist based on job performance and commitment to quality.

Feb 1998–July 1998 Chr. Hansen. R&D Analyst

Food Science Company

Mahwah, New Jersey

Assist in the formulation of FD&C coatings and compound color flavors for Research and Product Development.

Knowledgeable and competent in fluid bed processing, tableting, tablet coating and color matching.

Ability to conduct color assessment of powder blends to match and supply customer needs.

Increased productivity 100% by coordinating the upgrade of the R&D retain filing system.

Oct 1987–Oct 1997 Cookson Pigments. Inc., Analytical Chemist

Specialty Chemicals Manufacturer

Newark, New Jersey

Responsible for conducting industry standard chemical analyses of raw materials and finished products.

Performed industry standard metals analysis of wastewater to conform to environmental safety standards.

Performed industry standard water and solvent-based dispersion testing of high performance finished products.

Instrumental in the successful implementation of the ISO 9000 Quality Improvement Program.

EDUCATION

Feb-March 2010 Real Estate Sales Associate Gold Coast School Doral, FL

Oct 1997–Jan 1998 Microsoft System Administration PC Age Institute Fairfield, NJ

Jan 1995–Jan 1996 Financial Planning College for Financial Planning Denver, CO

Aug 1985-Jan 1987 Chemistry Major Kean University Union, NJ

Aug 1983-Jan 1985 Chemical Technology Essex County College Newark, NJ

COMPUTER SKILLS/RELATED INSTRUMENTATION

Proficient in SharePoint Environment, MS Office (Word, Excel, Access, PowerPoint and Project, Lotus, Adobe

Acrobat, EDMS, Agile Product Lifecycle Management System, MasterControl, TrackWise and Wisdom/FirstDoc,

SnagIt, SAP, AutoCAD, FrameMaker, Labware LIMS in Citrix, Stability System II, and Oracle.

Knowledge of Novell System Administration, MCSE Certification, Copley and Empower HPLC Software.

HPLC System, UV/VIS Spectrophotometer, Hi-Coater, Glatt Fluid Bed Coater, Tablet Press, DU-64

Spectrophotometer, AA Spectrophotometer, FT-IR, Density Meter, pH Meter, Viscometer, Digital MeltPoint,

Analytical Balance.

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