BioPharma Technical Writer /QC Associate

SUMMARY:

A Validation Engineering Technical Writer who performs Best Practices QA

Commissioning Document Review and Revision. Project Change Control

documentation DCO tracking, cGMP practices, Research and Development, FDA

Part 11, 210 &211 and 820 requirements for GMP's, GDP's, Document

Management, Protocol Specification modification processing. Performs red-

line editing, flowcharts initiatives for IQ, OQ, PQ manufacturing and

design process. Quality Manuals (QM), User Manual Instructions, Engineering

Specifications. Standard Operating Procedures (SOPs), Process Monitoring

and Summaries (PS) documents. Have demonstrated work experiences and

accomplishments within Pharmaceuticals Biotech, Chemical and Plant

Manufacturing based facilities. Knowledgeable of Manufacturing Packaging,

Calibration, Electropolishing, Bead Blasting and Validation processes.

Creates Artwork and Labeling, Presentation Designing, Data Management ISO,

QA/QC Trainer.

. Reviews Plant Operations Process Validation Engineering IQ, OQ and PQ

Protocol Document revisions.

. Creates Validation Protocol instructions and data collection tables

. Creates trainings visuals for approved Regulated processes.

. Administered and communicated official postings of official/proposed

regulatory correspondence of compendial information across business

units.

. Reconciles initial and previous workflow document versions

. Reviews Validation and Commissioning System Report for Master

Documents and Change Management

. Review DMAIC, FMEA and Module (3) Risk Management development - Six

Sigma processes.

. Review and Revise cleaning validations, SOP's gaps and deviations

change control initiatives.

. Maintain interfaces between the Deviations/Investigations and CAPAs.

. Assists SME's and stakeholders with annual FDA required course annual

certification trainings.

. Creates, organize and deliver new training programs and materials for

R&D/Plant Operations/HR

. Ensures Traceability of Functional Requirements documented by review

of Mechanical Completion designs and equipment testing.

EDUCATION/CURRICULUM VITAE:

Masters of Education

I.T. Technology and Design, East Stroudsburg University, E.S., PA

Bachelor Science

East Stroudsburg University, E.S., PA

SKILLS:

Professional Computer Skills, Microsoft Word, Excel, Outlook, PowerPoint

and Visio, Six-Sigma knowledge, CFR 21 Part 11, ISO 9000 knowledge, Share-

Point, Manuscript, DocuSphere, Learning Portal Self-study uploads

Compliance Wire, Net Docs 2.0, EDMS, Crystal Enterprise Reporting Systems,

Documentum, NAIO, Proficient-Infinity QS, LIMS, PDMS, e-Room, Track-Wise,

Access Database; Web-SS, Change Control process knowledge, (PDLC) Product

Document Development Lifecycle Testing knowledge and Calibration Report

Review. Guidance/SOP document numbering systems, SAP, Internal/External

Audit compliance, Database updating, Instructional Manual revision,

Research Associate for Project Development, e-Learning development,

training Global Regulatory Strategy (GRS), Learn/Confirm Grid, PDM-Product

Dossier Management, Financial Budgeting System Prophet, CRM Software, CICS

and Emerald Systems.

PROFESSIONAL BIOPHARMA/BIOTECH/MEDICAL DEVICE EXPERIENCE:

Personal Sick time Two Major Surgeries 09/2013 -

02/2014

Synthes-Depuy, Monument, CO - (Consultant) 06/2013

- 08/2013

Validations Specifications Engineering - Technical Writer

. Discussed and wrote new Process Validations procedure with Validations

Engineers assistance.

. Created and managed the entire IQ, OQ and PQ rewrite Process

Validation template for (VM) Validation Engineers.

. Responsible for Process Validations and Process monitoring and

Protocol and change control process.

. Addressed validations per FDA Audit and concerns for compliance

Validation Engineers

. Managed DCO, Responsible for Protocol Translation and Approval

Processes

. Managed weekly Focus review meetings with (PVE) Process Validations

Engineers and (PDM)

. Prepared computer validation documents such as Validation Plans,

Configuration Specifications, Test Protocols and Reports.

. Prepared Change Control documentation and execution test scripts

reports

. Performed risk-assessments analysis revisions and Visio flowchart

planning

. Provided a Quality system review as a team member, then developed and

implemented a remediation plan.

BioMerieux, St. Louis, MO - (Consultant-remote) 04/2013

- 06/2013

Compliance Documentation Specialist

. Assisted Systems Analyst Manager / SME with Protocol/Change Control

documentation management Controlled Data.

. Revised failed written Protocols which omitted significant system

execution and validations information.

. Reviewed Critical and Non-critical systems documentation for new

formatting initiatives and suggestions.

. Revised Document Details, Approval Requirements and Role

Responsibilities for Critical and Non-Critical Systems and Protocols

after approval process.

. Created new format for History of Revisions and Summary of

Changes/Justifications

. Created new Word formatting and Visio designs for Protocol Preparation

training guide instruction regarding types of Revision-Controlled Data

Process Flow and Systems Scripts.

. Developed SOP's and instructional training materials utilizing screen

shots and "How To" Visual learning presentations for newly created

systems document management process.

Roche, Lyndhurst, NJ - (Consultant) 10/2012

- 02-2013

Document Specialist/Workflow Coordinator

. Performed document lifecycle movement and workflow and Document

Transfer Development.

. Coordinated team Work in Progress (WIP) documentation and

distribution.

. Managed Trackwise and eDocs systems.

. Assisted Regulatory Compendial Affairs Office merger integration

processes, databases, network directories, historical products and

raw materials files, and library archive documentation

. Provided electronic workflow authoring, editing, review and approval

processes.

. Provided editing and proofing for Document Types: GMP's, Business

Scripts and Change Control requests, DFT's, Packaging Reports, SOP's,

Product Labeling, Drug and Safety Data Sheets, Sub-Contractor Records,

RM's, and QCS's,.

. Ran Daily Crystal Enterprise Reports and Report database and queries

J&J, Lancaster, PA - (Consultant) 02/2012 - 04/2012

Consent Decree -Technical Writer

. Assisted team(s) to manage cleaning validations and out of conformance

solutions and documenting manufacturing systems deviations and gap

data review for routine processes.

. Participated as team member to create and revise SOP's to correct

deviations per Consent Decree cited GAPS

. Revised or created product plan layouts and technical design and

Instructional manual changes.

. Developed and implemented quick reference spreadsheets for cleaning

manufacturing ops.

. Maintained updates in database via utilizing Sharepoint access and

other stakeholder tools.

. Assisted in preparing process / cleaning validation protocols and

summary reports.

. Managed site Change Control Dashboards, upload/authored for Sharepoint

site for entire team to access and review project notifications and

document modifications

Sanofi-Pasteur, Swiftwater, PA - (Consultant)

05/2011 - 12/2011

Best Practices, C&Q Validations Professional/Technical Writer

. Provided technical writing protocol revisions and other documents as

required by project.

. Reviewed and completed manufacturing system walk-downs and safety

inspections.

. Created Safety Hearing Conservation Trainings and Safety Data Sheets

for Production Bldg under construction.

. Assisted in standardizing data management documentation for system

execution and cleaning operating procedures.

. Maintained validations data revisions through review of commissioning

validations data-pack reports

. Coordinated with Regulatory Affairs QA/QC Manufacturing to attain

system testing results for report reviewing and submission.

. Implemented completion of change control, reviewed the evidence for

each identified items in the implementation plan and verified that

intended change was completed

. Reviewed and submitted mechanical system execution issues to system

owner for testing review/revisions

N. Biomaterials, Scranton, PA, - (Consultant)

10/2010 - 05/2011

Training and Development Manager

. Development/authored, revision, review, approval, and organization of

documents.

. Presented documentation for new hires classroom and on-site

performance and demonstration training.

. Developed and reviewed QA testing and record and tolerances

evaluation procedures and processes

. Provided OSHA Safety plant and Chemical handling and mixing trainings

and assessments

. Created Safety trainings and Instructional Safety Data Materials for

Warehouse Personal guidance

. Managed document lifecycle processes in enterprise Electronic Document

Management System (EDMS) and identify areas for improved productivity.

. Managed document control of the Master Production Record (MPR) to

production and packaging areas.

. Prepared module learning objectives, data, templates, system testing,

data results and reports

. Created and processes trainee performance certifications per FDA/EPA

regulations

Employment within Behavioral Care industry while seeking employment in

scientific field.

Wyeth, Collegeville, PA, - (Consultant)

R&D-Instructional Design Artwork Labeling, (Consultant) 09/2007

- 03/2008

. Created technical text for Pharma and EMEA, PDM, CCTRL presentations

. Wrote, maintained and designed uploads of lifecycle flowcharts,

processes and stakeholders toolkits

. Assisted, developed, monitored and reported weekly addressed

effectiveness and efficiency of the C-CTRL system and the document

lifecycle management process and dashboards.

. Created instructional documents, A & L design/C- CTRL for ELTAR, ELIS,

PDM and Meta Storm

. Wrote and revised technical documents to meet BoH compliance and SOP's

and GMP manuals

. Created and processed TPAR training reports and product conformance

. Complied and processed Standard Operating Procedures (SOP's) per EMEA

and FDA Rules and Regulations from Europe (RoW)

. Ensured that the change control impact assessment forms was completed

. Assisted in the validation to route the change through C-CTRL

implementation plan.

. Prepared presentations and maintained SAP Financial systems technical

and end-user manuals, SAP source data functions, storage, retrieval

and extractions.

Computer Horizons, Mountain Lakes, NJ - (Permanent) 05/2006

- 04/2007

Corporate Financial Associate (Division Closed)

. Revised various technical, written and (SEC) Securities Exchange

Commission quarterly filings.

. Provided internet technical support and due diligence and auditing

processes

. Created, revised 10-Q, 10-K, and 8-K Sec quarterly filings in concert

with CEO and Controller.

. Prepared, revised legal documents regarding Sarbanes Oxley (SOX)

compliances and audits.

. Monitored and prepared accounts receivable payment and balance

documents

. Prepared presentations and maintained SAP Financial systems end-user

manuals.

Sanofi-Pasteur, Swiftwater, PA- (Consultant)

11/2005 - 05/2006

Metrology - QA - Calibration

. Provided revision and creation from referenced material for GMP's and

FDA guidelines.

. Developed training curriculum for Human Resources for Metrology

presentations.

. Maintained validations for conformance and non-conformance procedures

and policies manuals.

. Complied with SOP's Standard Operating Procedure per FDA regulations.

. Maintained Metrology completed instrument calibrations documentation.

. Provided annual calibration and temperature analysis reports for out-

of-spec devices/systems

. Reserved conference rooms and audio equipment

. Developed and created technical material for employee dashboard

accessibility.

. Updated and maintained Metrology Metric System Safety and Quality

Performance Charts.

Novartis, Hackettstown, NJ - (Consultant) 08/2005

- 11/2005

Speaker Central Specialist/Research Analyst

. Coordinated and created synchronous training material and testing.

. Identified and wrote document standardized speaker processes.

. Assisted Regional Scientist and Medical Professionals with

Conference/Registration sessions.

. Managed a web based application to support the RSD with speaker

management initiatives.

. Provided and managed all speaker training database initiatives and

activities.

. Certified Medical Professionals through database file management for

product conferences.

. Defined and tracked brand product speakers for scheduled seminars and

web-cast conferences.

. Reviewed and monitored status of speaker nomination training, and

approve speaker nominees.

Contact this candidate