Document Control Specialist

Location:

San Diego, CA

Posted:

July 11, 2024

Contact this candidate

Resume:

Christine Guerrero

**** * ***** ***., **** **, Escondido, CA 92027, Cell: 760-***-****, Email:************@*****.***

Objective: Document Control Specialist in N. County San Diego area

W O R K E X P E R I E N C E

SeaSpine / OrthoFix Carlsbad, CA March 2023 – June 2024

Sr. Document Control

Full understanding of the DCO, DEV workflow in the Agile PLM environment, Web based: Pending, Submitted, CCB, Released, and Implementation

Ensures each document are utilizing correct document template and compares redlines to final copies.

Originate and prepare the DCO to describe a solution to the problem; as well as review the need of creating new part numbers

Coordinates the change with affected organizations such as Mfg. Engineering, Purchasing, Finance, and Regulatory and Quality Control

NEMOs Bakery Escondido, CA November 2020 – February 2023

Document Control / Supplier QA

Control SOP document revisions and SP workflows through the approvals and completion process.

Ensure SQF Register of documents is maintained and up-to-date.

Review Production, Maintenance, Sanitation, and QA records, for completeness and accuracy; obtains documented corrections for discrepancies.

Collaborate with Purchasing in the Supplier Quality Approval Process

Participate with Purchasing in resolving Supplier issues

Documents Root Cause Analysis and Corrective Actions for issues

Conduct Supplier 3rd Party Audits with Purchasing team; Supplier Verification is approved, and compliant – maintains records

Participates with Quality in Ingredient Food Safety Risk Assessments

Perform Document Control activities such as uploading documents and records electronically

Engage in all activities associated with preparation and editing of documents and procedures including performing reformatting, editing, and proofreading activities

Ensure consistent adherence to policy and procedure formats, style guidelines, and standards

Manages and maintains Employee SQF/GMP Trainings, includes Training Matrices

Coordinates QA Safety (includes matrix) and Quality trainings, every training is saved

Organizes and verifies QA logs, i.e. Cooler & Freezer check, GMP checks, Fruit Checks

Created and organized audit binders

VQ OrthoCare Vista, CA August 2012 – October 2020

QA Inspection Specialist/Complaint Handling Coordinator -

Reviews, processes, evaluates and coordinates the investigation of complaints within Medical Device QA Management database and to seek corrective action when required.

Receive Incoming and Final Inspect and Process all medical devices including Electro Medical devices, OEM knee/collar braces and determine disposition.

Manage and Audit Global ASL ISO certifications and FDA registrations, forms, log and work closely with Purchasing.

Responsible for determination of the root cause of the complaints.

Coordinates, implements, and routes all Complaints and CAPAs

Creates reports, charts and collects data to show current trends, monthly and quarterly Compliance Committee reports.

Life Technologies Carlsbad, CA October 2011 – August 2012

(Kelly Scientific Resources contract)

Document Control Specialist -

Knowledgeable of federal and other regulations, e.g. Quality System Regulations 21 CFR 820, ISO 13485

Demonstrates commitment to the development, implementation and effectiveness of Life Tech’s Quality Management System per ISO, FDA and other regulatory agencies.

Full understanding of the ECO workflow in the Agile 9.3 PLM environment, Java or Web based: Pending, Submitted, CCB, Released, and Implementation (Operator, Creator, Approver trained)

Key person to process Rebranding ECOs in the Doc Control group

Analyze and organized all submitted documents for any discrepancies, and rejects when necessary

In attendance and involvement with daily Doc Control Metrics and weekly Rebranding meetings

Complies with and practices cGMP; completes and updates all required training within time allowed

DexCom, Inc. Sorrento Valley, CA August 1, 2011 – Sept. 19, 2011

(Volt Services contract)

Document Control Coordinator –

Full understanding of the ECO workflow in the Agile 9.3 PLM environment, Java or Web based: Pending, Submitted, CCB, Released, and Implementation

Process and update all Training Records and Training COs in Agile and Excel Training Matrix

Responsible for updating ALL Satellite Training binders for all production areas

Enter all data, in Agile, for all new and term employees

Hygeia II Medical, Inc. Vista, CA Sept. 2010 – April 27, 2011 Document Control Coordinator –

Processed all Document Control Notices, TDNs, NMRs

Created and managed all QA Logs, Training Matrix, & Job Descriptions

Organized & Scheduled training for Operations Managers, Regulatory Rep and Quality Manager, R&D Supervisor, and all Assemblers

Managed and coordinated all documents, literature, BOMs, DWGs, SOPs, DWIs, etc., from cradle to grave

VQ OrthoCare Vista, CA July 2010 - Sept. 2010

(Ultimate Staffing contract)

Document Control Coordinator -

Provided support with CAPA, change requests, deviations and NCMRs

Processed all Nonconformance Finished Goods for Scrap, Sample, Return to Supplier and Use As Is

Communicated closely with Engineers, Purchasing, QA and Complaint Coordinator

Processed ECOs, TDNs and Initial Release of Drawings

Learned quickly and familiarized within a Medical Device working environment

Overland Data Storage San Diego, CA May 2008 – April 2009

(Office Staffing contract)

Change Analyst -

Full understanding of the ECO workflow in the Agile 9.2 PLM environment, Java or Web based: Pending, Submitted, CCB, Released, and Implementation

Originate and prepare the ECO to describe a solution to the problem; as well as review the need of creating new part numbers

Coordinates the change with affected organizations such as Mfg. Engineering, Purchasing, Finance, and Production

Prepares and gathers additional supportive documentation as required (i.e. Item Master, drawings, firmware, artwork)

Manages Item Master request form from generating form, attaching to PLM, forwarding to Purchasing, Cost Roll in PLM, closing in Log Sheet

Transfers all data from Agile PLM to BaaN IV PLM allowing a mirror image for Production, Engineering and Purchasing

Means Engineering Carlsbad, CA May 2006 - May 2008

Document Control Coordinator -

Self-Started the Document Control Department by working closely with the Quality Manager in developing a systematic and logical system

Full understanding of the ECO workflow in the Agile 9.2 PLM environment, Java or Web based: Pending, Submitted, CCB, Released, and Implementation

Trained and achieved the knowledge with very little supervision of Vista 8.0 PLM and Agile 9.2 PLM

Maintained and organized COs and Parts by placing them in its designated folders and/or directories

Worked and communicated closely with Mfg and Design Engineers to update all documents, AML, and any changes to the BOM

Trained and supervised two Document Control Coordinators with the combined efforts to serve all customers and their issues

Watkins Manufacturing Vista, CA Nov. 2004 - May 2006

(ManPower contract)

Configuration Control Coordinator –

Analyzes proposed changes of all Work Instructions, Method Sheets, Marketing proposed documentation. Manage all changes, distributes to relevant persons for approval

Coordinates recording of modifications for management control, work closely with Quality Management team to update all documentation

Confer with manufacturer or customer representatives to establish change-reporting procedure, including department managers to obtain additional information or to interpret policies and procedures for reporting changes in product design

Coordinated CCB meetings and managed forthcoming changes including needed approvals

Cox Communications San Diego, CA 1999-2004

Senior Admin. Specialist -

Associate Lenders, Inc. San Diego, CA 1998

Administrative Assistant -

E D U C A T I O N

Palomar College San Marcos, CA Aug. 2009 – Dec. 2019

Business Management

Univ. of Phoenix San Diego, CA 2003-2005

Information Technologies

Olympic College Bremerton, WA 1989-1991

General Studies