Bilingual (English and Spanish)
Pharmaceutical Document Control
Generate Document, Protocols, New Vendor Qualification
Analytical and knowledge management team training
Quality Assurance, GMP & SOP setting within the Pharmaceutical Industry
Professional Client interface leading to client satisfaction
Analysis and improvement planner for process improvement
Extensive with filling, auditing, archiving, inventory and maintaining & creating paper based
Strength in oral/written communication and interpersonal skills
Organization, communication and computers skills
Provides document writing support to validation engineers
Create validation document from standard templates
Provides input for the development of the standard template and with respect to procedures, process, SOP’s and standard procedures
Protocols review, routing, and signatures of approval
Inventory functions
Purchase orders
Batch records review
Strong experience on ECR, URS, EWP, IQ OQ, PQ, SR, FAT, SOP’S, GMP

Experience:
Nypro Jabil Company 08/04/2016
Quality Documentation Administrative

Responsible for the Document Control Area and compliance with Document Control.

Responsible for administering the company's controlled documents in accordance with customer and company requirements.
Responsible for implementation and maintenance of the company document control system, reporting on the performance of the document control system for review and as a basis for improvement of the document control system.
Establish/maintain procedures for maintaining documents and change control of documents.
Compile and maintain control records and related files. Release blueprints, drawings and engineering documents to manufacturing and other operating departments of all clients.
Determine and enforce - through functional groups - document control requirements in order for the company to meet internal and external needs.
Confer with document originators or engineering liaison personnel to resolve discrepancies and compile required changes to documents.
Responsible for assuring that all procedures regarding documentation and documentation practices are followed throughout the organization.
Main contact during Audits on documentation.
Receives customer complaints, issues formal notifications, maintains status reports and logs, prints formal answer, and mails/distributes to customers.
Maintains and dispositions of Quality Records (obsoletes and current).
Responsible for management and compliance with Documentation Control at NWQS system.
Complies with all Manufacturing Procedures and Instruction applicable.
Migrate new Document to a new format template.

Microsoft Humacao, P.R. 12/22/2014 06/2016
QA Inspector
Coordinate with Manufacturing to determine test/inspection schedule demands.
Prioritize QC Inspector activities according to manufacturing demand.
Analyze manufacturing processes and identify improvements to determine more efficient inspection methods or techniques.
Consistent with the quality plan perform inspections or process verification run, including process controls.
Performing incoming inspection of material prior use.
Assist on the first article inspection of the part to ensure conformance prior start running the job.
Perform final inspections on productions parts, ensure that inspections are performed with the proper gages or inspection equipment and document inspections.
Review documents and inspect and sign off parts on the service provided for compliance before releasing into production of for shipment.
Share point documentation.
Manage the product release.
Ensure parts/product comply with all customer and SOP requirements.
Assist the QC Technician with all Manufacturing/Inspection gages and inspection equipment.
Maintain a log of the inspection equipment in the plant.
Maintain calibration record available and accurate.
Manage Non-Conforming materials.
Evaluate quality requirements and identify equipment’s needed.
Assist identifying technical issues and concerns.
Assist on investigations of Non Conformance.
Provide training on use of non-contact inspection equipment and associated programs (vision systems, comparator.
Maintain and update Quality records and databases as required.
Provides objective performance input toward inspection employee appraisals
Support QC Inspection activities:
Incoming, in-process and final quality inspections on product, components, services or at supplier, facilities in accordance to documented instructions; also to include review of supporting documentation.
Collection and review (to appropriate material standards to ensure requirements are met) of supplier data packages in accordance with documented instructions.
Document and record the results of inspections performed in writing and within system.
Detection of non-conforming materials and preparation of supporting notifications in system and execution of disposition as directed.
Test hardware forecasting and inventory management.
Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations
Updates job knowledge by participating in meetings/educational opportunities
Prepare Manufacturing Procedure and edit by regulations.
Approval inspections, Batch record reviewer.

Technical Documentation Specialist Support BD Becton Dickinson 06/02/2014-10/31/2014
Cayey P.R.

Coordinate document control workload including assessment of document revision queue and timelines.
Administer controlled document templates and provide document format guidance to end users.
Perform technical writing and clerical/general departmental support for the preparation/edit of standard operating procedures (SOP), and other controlled documents.
Maintain master document files for controlled documents. Coordinate and perform document processing activities, such as tracking status of document routings, initiating document revisions, issuing/distributing for signature approval and employee review, and assuring implementation of documents.
Coordinate biennial review process for SOP’s, Batch Records, and Batch Records Worksheets, ensuring documents are reviewed when scheduled and revised when needed.
Maintain archival of controlled documents, including off-site archiving/file storage program.
Perform quality control electronic files (master files, share points, electronic folders.
Edit documents in accordance with formatting and template requirements.
Redline align and document conversion
Project planning and coordination for any projects that have potential impact to any controlled documents. Gap analysis on existing document control systems and evaluate new systems for performance improvement.
Act as the “runner” for providing documents required for review during regulatory/accreditation inspections.
Assist in maintaining all QA related databases, and perform data queries, as required.
Batch Record Review
Purchase orders
Ability to modify documents in MS Share Point.
Translate documents as required, ensuring that the meaning of the source text is retained.
Write, edit and manintain documentation in a controlled fashion. Collaborate with responsible personnel and areas experts to gain an undestanding of the technical terms and process/product requirements. Research legal, technical and scientific phraseology to find the correct translation. Ensure accuracy and completeness of technical and operational translated documentation
Use the appropriate technology such as internet, email, as research tools throughtout the translation process.

Experience Technical Writer Qualitest Pharmaceutical 09/20/12 to 12/20/2013 Huntsville Alabama

Generate Vendor Qualifications Protocols.
Edit proposals, technical reports, and presentations for grammar, clarity, and consistency.
Format proposals, technical reports, and presentations.
Design Microsoft Word templates for documentation.
Creates Validation documents from standard templates.
Assist in the preparation of briefing slides.
Assist in the design and development of training and communication documents.
Self-directed and able to perform assignments independently, and at times, with management staff under time constraints and stringent deadlines.
Develop and prepare technical documents sus as Investigation Reports, SOP, and other sentive manufacturing documents. Investigate and generate Investigation Reports on manufacturing discrepancies. Responsible for generating, tracking and ensuring implementation of corrective and preventative actions. Generate and assist in the completion of Manufacturing Change Controls.
Developed process for engineering validation file management and editing processes affecting more than 1000 protocols, audited and managed publication/equipment file relationships, Established format for protocol reporting and managed approval process requiring coordination for 5-18 engineers, Edited between 8 and 20 protocol reports weekly for standard English usage and grammar, Manipulated document formats to enable editing by engineers while pointing out potential trouble spots in the document, Developed protocols and white papers to identify, assess, and propose solutions to problems encountered in protocol processes, established and direct items. Physical and electronic. Provides document writing support to validation engineers, creates validation document from standard templates, Provides input for the development of the standard template and with respect to procedures, process, SOP's and standard procedures.
Strong experience on ECR, URS, EWP, FAT, SOP's, GMP, IQ, OQ, PQ, SR.
Purchase orders requisitions, Change order request and deviations.
Router documents for signatures.
Audit and manage publication/equipment file relationships.
Established format for protocol reporting and manage approval process requiring coordination for 5-18 engineers
Manipulated document formats to enable editing by engineers while identifying trouble spots in the document
Batch record review
Developed protocols and white papers to identify, assess, and propose solutions to problems encountered in protocol processes
Generate Vendor Qualifications Protocols
Provides document writing support to validating engineers
Creates validation document from standard templates
Provides input for the development of the standard template and with respect to procedures, process, SOP’s and standard procedures.

Patheon Manati Administrative Assistant 10/26/11-8/17/12 Manati, P.R.
Schedule executive meetings and travel, assist executive with preparing for meetings, presentation, and documents, answer phone calls and email.
Edit existing documents and keep records of any changes made
Perform managerial duties such as control of corporate accounts, payments for bills, and service providers.
Execution of export documentation internal or external destinations
Generate requisitions, process purchase orders, and follow up internal approval purchase orders
Generate change order, check requisitions, waiver, and vendor information
Making and distributing order for the company
Customer Service techniques
Making check for difference company’s and employees
Preparing and publishing reports, supervise employees
Support with vendor schedules, visitor and arrangements, and calendar maintenance
Typing, filling, proofreading, obtaining e-journals, telephone coverage, travel reservations, expense statements and reconciliation
Performs filling of all documentation as per corporate policies and procedures
Inventory functions
Request for proposal process, coordination of meetings, metrics, reports, resolutions of situations, and any other related task

Auto Pack Engineering Corp. Administrative Assistance 4/20/11-10/24/11 Caguas, P.R.
Making and distributing orders for the company
Data entry
Customer service techniques
Pay Roll
Vendor communications, resolve escalate issues with vendors
Codes payable invoices with correct general ledger coder dot ensure proper entry into computer.
Inventory functions
Purchase orders
Batches pre-coded invoices by adding invoices together on calculator, run related reports
Process check on a daily basis for payments request that have been pre-approved
Account payable & account receivable

Patheon PRO Consolidation Project Technical Document Specialist 3/13/2011-9/10/11 Caguas, P.R.
Perform all required activities of the document control specialist, including document creation, revision, routing, approval, distribution and retention
Batch record review maintain the controlled supply of GMP, SOP’s documents originating within the company.
Review documents to determinate distribution requirements and process distribution request according to set procedures.
Retention are maintaining documentation control as per corporate and regulatory requirements
Ensure the writing, editing, reviewing and approving of document in a timely manner to meet establish deadlines. Updated and maintain documents, as well as other database, and perform data entry for tracking documents.
Preparing and publishing reports
Daily reports and certification, new vendor qualifications

F.S. Surveying Corp. Secretary Caguas, P.R. 1/25/05-8/23/10
Making and distributing orders for the company
Customer Service techniques
Pay Roll, Daily reports and certification for payments
Making check for difference company’s and employees
Preparing and publishing reports, supervise employees
Account Payable & Account Receivable
Inventory functions
Purchase Orders

VA Hospital Professional Medical Billing Examiners. xxx-xxx-xxxx

VA Medical Hospital San Juan, P.Rxxx-xxx-xxxx

Execute a variety of medical billing duties among medical billing function party join inquiry & reimbursable code computerized software program. Verify and adjust several medical provider accounts. Resubmits to provider denied pending invoices.

Skills
SAP
Expert user of Microsoft Office Suite
Excel
Word
Power Point
Microsoft Outlook
Acrobat Professional
Customer Service Technique
Data Entry

Education:

Associate Degree, Edic College, Caguas, P.R.
Computerized Secretarial Sciences & Technical Writer Certificate
Interamericana University of P.R.
Elementary Sciences

Reference

Will be provided upon request
Other experiences VA Hospital Medical Billing ICD9,CPT, Knowledge of medical terminology.
Willing to relocate

Amneris xxx@xxx.com

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