Debra Freeman Email & Phone Number

Denver, Co, Us

Denver, Colorado, United States

Denver, Colorado, United States

Worked as a Quality Systems Analyst for a small, dynamic and growing company. Team members had to be flexible and work in many areas.Quality Roles-Managing the Document Control, Archiving and Training Systems including metrics and reports. -MicroSoft Word Power user, creating templates, Writing work instructions and redlining procedures. -Administrator of the electronic signature system including validation and as needed assistance.-Tracking,Monitoring and reporting on Regulations, including EN, ISO, EU, ASTM, 21 CFR, etc.-Assisted with Final review and closure of production builds.-Certified Auditor, helped with internal Audits, assistant to Lead Auditor during External Audits.-As needed, product or label review in a clean room environment.Operations Roles-Monitoring Sales Orders, entering order into CETEC system and preparing Sales Orders packet for production.-Was cross-trained in Receiving and ShippingOffice Management - Monitored/ ordered and stocked office supplies, First-Aid kits, kitchen, cleaning and bathroom supplies. -Monitored provider and ordered service for copiers, doors and water cooler.-Organized/ tracked company keys-Greeted guests, answered phones and ordered, staged food for meetings.-Was an Events team member for 3 years, assisting with budgeting, planning, decorating, staging and cleaning

Performed Document Control and Quality Engineer tasks for various types of projects including ITAR, Medical Device, Aeronautics, Design and ManufacturingDatabase Software used: Jama, Jira, Agile, Silicon Expert, TipQA and JDEJama: Site Power User for Jama • Designed document export templates/ component structures for consistent and professional documents • Created a method to quickly fix common export issues in large documents • Mass specification data importing • Roundtrip data imports • Filter creation • Designing and verifying Trace Matrices • Mass uploading upstream/ downstream traces including Test Runs • Performed independent QA Reviews on Test Runs, Specifications and Test Cases • Syncing Requirements or Test Cases • Exporting and preparing procedures for client review. Agile: Built and routed change orders for documents and parts • Updated BOMs with vendor details and inventory instructions • Prepared client approval packages • Exported pdx files • Maintain DHF Files for projects • Performed proofreading/ redlining and quality reviews on ECOs as requested • Needed ITAR Clearance.Used Jira to tracked project non-conformances and regression research • MicroSoft Word Power User, formatting, redlining, Creating macros, Table of Contents, Style sheets • Performed and Tracked Production Part Approval Process (PPAP) reviews including balloon drawings and 3 part Fair comparisons • Created RoHS compliant Off The Shelf Part Specifications • Wrote work instructions on Jama best practices and project specific design • Vendor communication for regulatory updates, including RoHS, Reach and J-STD-001, using Silicon Expert, TipQA, Agile and JDE • Executed Validations when requested • Worked with clients and coworkers from around the world using One Note, Jabber, Outlook and Go-To Meeting

Formerly Reglera

Responsible for managing daily document control activities and facilitating this process throughout client companies; processing change orders; Ensuring quality processes and good documentation practices are being executed at all stages of the change control process; Tracking documents through the change process; Interacting with document approvers to ensure document change control loop is completed; Releasing documents in the document control system per defined procedures; Formatting and uploading documents in controlled electronic system for client access; Managing reports and metrics regarding documents within the system; Working with training coordinators to ensure metrics are complete and updated

Performed all Document Control functions to assure compliance with the company quality system; Assisted in an overhaul to standard operating procedures regarding Document Control; Performed site-wide training lectures concerning changes to the Document Control Process; Guided co workers through the change order and Annotated Draft Document processes; Enforced change control procedures, offered guidance and ensured that redlined changes were properly documented and reviewed; Ordered and tracked translations for labeling; Guided labels through change order, Print Authorization, Vendor Blue-Line approval, and inventory control procedures; Responsible for performing Controlled Document Audits; Document Control representative for company in the 2007 FDA Audit.

Maintained all Document Control functions to assure compliance with the company quality system; Coordinated the change order process and verified that all changes are properly implemented; Responsible for tracking documents through the system; Maintains a master list of all controlled documents; Controls the distribution and accuracy of all the documents used in Manufacturing, QC and QA for company products; Ensures that all the quality system documents are kept up to date and accurate; Ensures that all obsolete documents are not available for reference; Enforce approval and change control procedures; Assure secured access to all controlled documents; Provides manufacturing with master copies of Package Inserts as needed for the assembly of kits; Responsible for performing Annual Document Audits; Assisted in the review and approval of manufacturing labels; Managed and coordinated approval of labels designed for Outside Manufacturing Partners

Ensure that control site SOP, Global SOP, Specification, Analytical Method and Laboratory Procedure Manuals are frequently updated; ensure that Work Order filing is completed accurately and in a timely manner. Assist coworkers with locating, checking out, and proper re-filing of work Orders; Assist team members with Document Processing and Monitor turnaround time for processing Requests; Handle co worker questions that address DMS systems and procedure issues; Work with FileMaker Pro Database System to track, control and relay information and Document Processing Requests; Scan documents and/or training coworkers on scanning procedures.

Maintain Document Control system, procedures and databases in accordance with regulatory requirements; Train coworkers on DCS procedures; Assist coworkers in developing and writing procedures and forms; Initiate changes to procedures; Assign revision numbers and control distribution of current revisions; Manage and maintain technical review schedule; Assign and control production part/ lot number database; Assist Quality Assurance/Regulatory Compliance (QA/RC) Manager with the development/maintenance of the Quality Management System and Regulatory training modules, as well as conduct training of employees to these modules; Ensure that training records are kept in accordance with internal procedures; Track and update External Standards; Demonstrated ability to coordinate and perform QA/RC Manager tasks during a three month interim period with vacant QA/RC Manager position.

Greeted/ screened visitors; Answered multi-line switchboard; Sorted mail; Tracked Employee Vacation Time; Organized Mail Merge response letters; updated the Employee Safety Manual, Created CDs and Books in an H/R aid project for company distributors; Assisted with outgoing bills, data entry and filing; Assisted other departments as needed.I worked under the name Debra Smith at Mark VII.

Bachelor Of Arts - Ba, Computer Science

Education record