PROFESSIONAL EXPERIENCE

Confidential

Sr. Document Control Specialist/SME/Trainer

Responsibilities:

• Manage, track, and report items that are currently in our ECO process workflow.
• Responsible for defining, documenting, Implementing, and reassessing all Processes.
• Complete and Present ECOs in phases to the stakeholders. Collect Approvals on the spot.
• Revise and edit existing parts in SolidWorks (CAD) and route the change through the approval workflow.
• Designed and implemented a Signature and Approval Matrix which matched approvers to document types.
• Generate Standard and Custom SKUs in ERP.
• Build and edit BOMs in ERP.
• Address all system issues immediately, think critically on my feet, find solutions, assess the risk, and release.
• Design and Maintain Sku Matrices, which break down product line SKUs to provide a key for the user.
• Steadily manage 2 - 3 employees, divide the tasks up between us all, track progress, and report on them weekly.
• Documentation SME - Review, Redline, approve/reject items that are moving through the workflow.
• Write test scripts for the PLM/PDM integration and call the UAT/UX meeting to test functionality.
• Replicate software errors, create a video of the sequences, and submit supporting documentation to IT.
• Coordinate with each engineer daily to ensure that all projects are ahead of schedule, or at worst, on time.
• Upgraded the company from paper-based to EDMS (M-Files PLM) in the middle of the pandemic, remotely.
• Create/Delete M-Files users when needed. Assign each employee to an approval group in
• Technical Writing - Write SOPs, Work Instructions, and Workflow Charts for M-Files & PLM at Austin/Kunshan
• PLM Integration - Worked closely with the PLM implementation team to launch PLM using Agile Methodologies.
• Corporate Trainer - Design, write, and Maintain all M-Files Training Curriculum (.PPT, Video, .docx etc.).
• Ensure that training courses are complete and that we are in compliance with completion dates.
• Provide weekly interactive virtual PLM systems training (PLM-Discrete) for employees.
• Responsible for storage and destruction of documents, according to the Record Retention Policy.
• Export data from all systems, clean up the .xlsx .csv files, and deliver them to management.
• Clean, edit, and collect, appropriate Metadata fields, and consistently update the data for better search queries.

Confidential

Technician/Agile Super User

Responsibilities:

• Change Analyst - Submitted ECOs, DCOs, MCOs, into the paper-based workflow.
• Lead effort to switch from DOS to Windows by manually transcribing.
• Assigned appropriate approvers to item revisions. Approval workflows in Agile PLM.
• Q/A & Q/C batch records. Followed cGMP procedures.
• Responsible for reviewing/editing any documents before passing them through the workflow process.
• Wrote and Created company templates for controlled documents and forms.
• Technical Writer - Wrote/edited work instructions and SOPs in for new Agile PLM processes.
• Relabeling I.V. bags - Responsible for the BOM revision edits to replace logo after acquisition.
• Locate and fulfil document requests from personnel around the plant.
• Maintain paper files according to record retention policy.

Confidential

Control Specialist/Shipping Mgr.

Responsibilities:

• Was responsible for ongoing revision control, workflow compliance, and processing all incoming ECNs.
• Picked/Packed/Shipped hundreds of orders a day.
• Used FedEx to enter and print all shipping labels.
• Was responsible for the organization and maintenance of the electronic and manual filing systems.
• Was Responsible for organizing the warehouse items and alerting the proper departments when product is low.
• I was the Documentation SME reviewer and approver.
• Wrote and released work instructions for the Change analyst and originators in Agile PLM.

Confidential

Document Control Analyst

Responsibilities:

• Was responsible for ongoing revision control and the processing all incoming ECOs, DCOs, and MCOs.
• Certified trainer and Super User of Arena PLM.
• Wrote/Created templates, forms, work instructions, and SOPs.
• Created, edited, revised, maintained BOMs.
• I supported the Audits as the scribe during the audit, sitting in the back room.
• Was responsible for auditing other departments for quality.
• Wrote processes and procedures for document control.

Confidential

Document Control Coordinator

Responsibilities:

• Trainer/Super User of Agile PLM/Master Control software, in classroom and one-on-one settings.
• Was responsible for revision control and processing all incoming ECOs, DCOs, MCOs through EDMS.
• UAT - Attended User Acceptance Training to validate Agile PLM and ensure.
• Processed all email inquiries coming in from customers to the Document Control Center.
• Assisted with audit support for BSI, Internal, ISO:13485 and FDA, and international audits.
• Technical Writer - Wrote/Edited Work Instructions, SOPs, and Specs.
• Documentation SME reviewer and approver of all documents moving through the system.
• Was Responsible for maintaining training compliance for the Austin location.
• Exported measurable data from the EDMS, reorganized and added data to pivot tables.