CECILIA RAMOS

408-***-**** adxthv@r.postjobfree.com

LinkedIn email: www.linkedin.com/in/cecilia-ramos-3-quality

SKILLS

SAP

Data entry

Databases, System documentation

Document Management

Documentation

Employee training

Workflow

GMP

ISO 9001

ISO13485

Sales Force (CQ) Compliance Quest eQMS

Confluence

Jira

MRP

PLM

Solidworks

Proficiency in SAP

Digital file organization

Workflow coordination

Microsoft Office

Agile

SharePoint/PLM System

Teamcenter

ERP Systems

Product Center PLM

WORK HISTORY

Pear Therapeutics

Sr. Documentation Services Specialist // San Francisco, CA // May 2022 to August 2022

Oversee the document control process for product development process records and Design History File records.

Review document Change Orders, document content and accompanying eQMS information for implementation of accurate format, dating and Good Documentation Practices (GDP)

Process Change Order requests through the approval process to final approval signatures and release within electronic Quality Management System

Collaborate with cross functional product development teams during recurring product development meetings and provide status of pending Change Orders

Produce documents that reflect departmental and company-wide processes and conform to the requirements of the electronic documentation system.

Roche

Sr. Documentation Services Specialist // San Jose, CA // July 2019 to May 2022

Support implementation and company-wide training efforts associated with deployment of Electronic Document Management System (EDMS).

Manage entire document lifecycle including document issuance, tracking of document numbers, format review, routing documents for review and approval, scanning and filing documents in EDMS System.

Establish/maintain procedures for inspection readiness, good documentation practices, and change control.

Assist staff with computer application needs for document control and maintenance of quality records.

Liaise with Project Management & team, Client and Sub-contractors effectively and resolve problems and issues relating to documentation.

Enforce - through functional groups - document control requirements in order for Ariosa to meet internal and external needs according to CLIA/CAP, NY, ISO 13485, IVDD, and FDA (QSR) regulatory standards including all applicable local, state, national and international requirements.

Ensure documents and records meet quality standards prior to submission to QA.

Ensure documents follow standard formats and review quality records to minimize typographical errors and other types of documentation errors.

Maintain onsite and offsite documentation storage as applicable.

Communicate and escalate any issues or concerns to management.

Responsible for Control/Track/Issue of complete project documentation such as incoming and outgoing correspondence, site instructions, change orders, Submittals, and other forms of pertinent documents from client and subcontractors (including internal documents).

Assisted in Audits.

Backroom assistance assigning, Prepping and Vetting Documents for Audit.

Maintain outgoing Log for requested Documentation.

Monitored and created control reporting to track performance of system and process integrity, vendors, internal workflows and SLAs.

Uploaded company procedures and policies to EDMS, routing for approval and training.

Gala Therapeutics

Document Control Specialist // Menlo Park, CA // February 2019 to July 2019

Responsible for document control Independently performs day-to-day Document Control activities; including process DCN packages and review for correctness and completeness; monitor and update in-process documents; create, assign, and archive logbooks; maintain the electronic document management system; maintains Master Documents in the Document Control System.

Performed duties in support of established records management procedures, including scanning, filing, and managing records for storage and retrieval.

Assisted in the preparation of document control metrics and reports.

Provided support for regulatory inspections.

Worked with CAPA owners to plan and document investigations, action implementation and effectiveness verification on time and according to procedure; ensure effectiveness verification is successful.

Supported Project management for various company activities.

Provided metrics on processes.

Contributed to design and implementation of overall corporate documentation standards, numbering conventions and templates.

Managed training courses, setup, and maintenance for document control systems.

Work with Training Department to assign Training and New Employee training

Use existing procedures to perform daily hands-on calibration work, ensuring calibrations are performed as scheduled and as defined by calibration program SOPs

Identifies equipment that fails calibration, uses manufacturer’s manuals, etc. to access and perform adjustment to meet specifications, or dispositions equipment as requiring repair.

Works in both laboratory and manufacturing environments.

Removes & re-installs test equipment from stations using safe practices.

Roche

Document Control Specialist // San Jose, CA // February 2017 to January 2019

Support implementation and company-wide training efforts associated with the deployment of the Electronic Document Management System (EDMS).

Manage the entire document lifecycle including document issuance, tracking of document numbers, format review, routing documents for review and approval, scanning and filing documents in the EDMS System.

Establish/maintain procedures for inspection readiness, good documentation practices, and change control.

Assist staff with computer application needs for document control and the maintenance of quality records.

Enforce - through functional groups - document control requirements in order for Roche to meet internal and external needs according to CLIA/CAP, NY, ISO 13485, IVDD, and FDA (QSR) regulatory standards including all applicable local, state, national and international requirements.

Ensure documents and records meet quality standards prior to the submission to QA.

Ensure documents follow the standard format and review quality records to minimize typographical errors and other types of documentation errors.

Maintain onsite and offsite documentation storage as applicable.

Communicate and escalate any issues or concerns to management.

Responsible for reviewing batch records aligns with the procedures and content, updating logs.

Experience in Batch records review and Product release activities for Medical Devices.

Collaborated across departments and levels of management to gain consensus on procedural documentation.

Contributed to design and implementation of overall corporate documentation standards, numbering conventions and templates.

Pulse Biosciences

Document Control Specialist // Millbrae, CA // November 2016 to February 2017

Process Pulse Biosciences' design and quality system documentation, product structures, manufacturers, equipment records, engineering change order process, non-conforming materials process, and corrective action process.

Develop and maintain processes, procedures, and work instructions for system usage and train users accordingly.

Manage and oversee all product labeling from artwork creation through printing and implementation.

Maintain Standards/Regulations/Guidance library.

Ensure that all applicable standards/regulations/guidance to Pulse Biosciences quality system and products are available and up to date.

Support Pulse Biosciences training program.

Establish training monitoring or tracking methodology and ensure that employee training is up-to-date and complete per (employee) defined training needs.

Ensure all documentation complies with Pulse Biosciences Quality System policies and procedures and maintain current knowledge of GMP/QSR and ISO/MDD regulations.

Becton Dickenson

Product Document Analyst // San Jose, CA // June 2016 to October 2016

Facilitate ECR Coordination step by analyzing and assisting in preparation of ECR s by cross-functional associates.

This includes assembly of necessary documentation and SAP objects of record (i.e.

Materials and documents).

Manage entire ECO Process specific to their focus and responsibilities, and provides guidance and training, where needed.

Assists in development and evaluation of new processes and procedures.

Also, analyzes existing processes and procedures to suggest continual improvements.

Prepare, create, and maintain various types of documents such as drawings, quality documents and manufacturing specifications for client products and services.

Performs data entry functions as required by business processes and responsibilities.

Maintains department activities such as Quality Document Review Process working with cross-functional managers to review and update Quality System documents.

Monitor corporate external standards system process and maintains local procedures to ensure compliance requirements are met.

Boston Scientific

Document Control Specialists // San Jose, CA // December 2015 to June 2016

Processes change orders for the site.

Audits changes, Bill of Materials, and drawings for accuracy and completeness.

Routes ECOs, MCOs, CRs and Deviations in Agile and Windchill PLM electronic system.

Manages document control and quality systems files.

Assists in developing processes and systems needed to manage quality compliance program.

Provides support to various departmental initiatives and projects.

Use existing procedures to perform daily hands-on calibration work, ensuring calibrations are performed as scheduled and as defined by calibration program SOPs.

Scheduled all on-site and off-site calibration events before the expiration of support equipment.

Independently identify and implement improvements to quality and effectiveness of products and processes.

Facilitates Quality initiatives to assure compliance to QSR/ISO throughout company.

Supports investigation, prioritization, and coordination of proposed documentation changes.

Provides technical assistance for quality problems.

Uploaded company procedures and policies to EDMS, routing for approval and training.

Worked with internal staff to process documents and sent for closing.

Genentech

Project Coordinator // South San Francisco, CA // March 2015 to December 2015

Report to PTAC group, providing customers with methods and tools to capture, manage, store, preserve and deliver information, content, and documents related to Engineering Projects in Lifecycle and Touchpoint.

Project controlled documents and engineering drawings.

Working closely with project managers, contractors and other members of Project Engineering group, and liaising with Roche/Genentech.

Record Information & Knowledge Management Group.

Responsible for tracking, maintaining, scanning and storing Project documents and drawings in both paper-based and electronic formats.

Oversee effective change control for all Project controlled documentation, ensuring that drawing and equipment numbers are issued in accordance with related Engineering practices.

Developed web parts for querying/maintenance protocol contents in customized SharePoint list.

Planned and arranged meetings with external organizations and individuals, enabling all parties to meet and discuss project progress.

Gathered requirements for ongoing projects and organized details for management use.

Bruker Daltonics

Document Control Specialists // Fremont, CA // April 2013 to September 2014

Coordinate required activities needed to review, update, and process-controlled documents and coordinate weekly ECO Meetings.

Administrator of Solid works EPDM System, Maintaining Engineering drawings & Assembly work instructions.

In document control center to ensure that, all users have latest revision of appropriate documentation in timely manner. process for quality documents and records per ISO 9001-2008 and 13485 standards.

Coordinate the training program for all new employees with functional area managers and provide status of training needs or deficiencies, including reporting.

Maintain Quality System documentation and respective department policies, ensuring quality compliance.

Coordinate with engineering and product management departments and develop and implement Manufacturing Plan for products.

Responsible for creating, monitoring and maintaining the corrective action database including periodic reviews with functional area managers.

Maintain CAPA Database for root cause analysis/determination, action plans and monitor checks for the effective and timely completion of CAPAs.

Prepares Monthly reports for MRB, RMA & RTV by collecting, analyzing, and summarizing data for Managers Monthly meetings.

EDUCATION

De Anza College // Cupertino, CA // Associate Degree - Liberal Arts- 2021 (Currently enrolled)

Certificate of Completion - Electro/Mechanical Drafting

San Jose City College // San Jose, CA // 1985

Certificate of Completion - Electro/Mechanical AutoCAD 2012 Intermediate

De Anza College // Cupertino, CA // April 2012

Certificate of Completion - Electro/Mechanical AutoCAD 2012 Beginning

De Anza College // Cupertino, CA // January 2012

Certified IPC Specialist (J-STD-001) 9/14

IPC International // San Jose, CA // September 2014

GED

Adult Education (San Jose CA) Certificate: GED // San Jose, CA // June 1978

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