Document Control Specialist

Robert Crespin

**** **** ******, *** *****, CA, *2102 619-***-**** ******.*********@*****.***

https://www.linkedin.com/in/robert-crespin

SUMMARY: A Document Control specialist with experience in processing all incoming and outgoing documents in document control databases, including electronic logging, scanning, distribution and various storage needs.. Major strengths include: Implementing and administrating documentation that conform to ISO 9001 & cGMP requirements. Coordination of releasing and revising project documentation for manufactured items with supply chain, design engineering, production, and program management. This includes the implementation and auditing standard operating procedures, regulatory standards, quality documents, Engineering Change Requests (ECRs), training support activities, supporting internal audits, and adhering to Good Documentation Practices. Organized reliable filing systems of all electronic and paper- based GMP documentation. Participated in the certification of FDA submittals. Maintenance of QMS documentation and archival records. Also, I am proficient in Windchill, SAP, Agile, Oracle, Solid Works, and Master Control. A dependable, well-organized professional who communicates effectively.

KEY STRENGTHS:

Change Management & Control

Commercial/Military/Biomedical

Document Control Management

ISO 9001 Certification

cGMP Certification Auditing skills

MRP/ERP/PDM Database Apps

21CFR Part 11 regulatory requirements

ISO 13485 regulation experience

PROFESSIONAL EXPERIENCE:

Becton Dickinson (BD) 2025

10020 Pacific Mesa Blvd.

San Diego, CA 92121

Requirement Analyst/Documentation Administrator

As a Requirement Analyst, I updated controlled documentation in DOORS and SAP, by supporting Product Requirements Documentation as well as System Engineering Specifications for the manufacture of Drug Infusion biomedical devices. This involves working closely with Sustaining Engineering, Project Management, R&D and Regulatory.

I am also responsible for exporting data from DOORS into data reports in order to conform to the requirements-based documentation that is controlled in BD’s ERP system (SAP).

Philips 2021 – 2024

Image Guided Therapy Devices

3721 Valley Centre Dr.

San Diego, CA 92130

Document Control Specialist/Change Administrator

As a Document Control Specialist, I provided the expertise of processing, auditing, and the final implementation of Engineering Change Tasks and Engineering Change Notices to the various image guided therapy devices that are utilized by hospitals and clinics worldwide.

I processed, reviewed, and audited all Engineering Changes for both disposable devices as well as image guided console systems that are utilized by surgeons. This involved implementing Quality Documents, creating & revising SOPs, Work Instructions, and processing and migrating change requests in Philip’s PLM/ERP system (Windchill/SAP). Created a pilot program to utilize collaboration review of all changes within the PLM tool that increased efficiency of turnaround time by 30%.

I am also very proficient in working very effectively with Team members (Project Management, Engineering, Quality, CAPA administrators, and Regulatory).

Hologic, Inc. 2020 – 2021

10210 Genetic Center Drive

San Diego, Calif. 92121

Document Control Administrator

As a Document Control Administrator, I provided the expertise of processing, auditing, and the final implementation of Engineering Change Orders to the configurations for the entire biomedical diagnostic assays. This provided Covid-19 RNA molecular testing capabilities. This is an integrated system that uses the proprietary Panther system that is the forefront of automated molecular testing capabilities used in labs worldwide.

This role involved working closely with Engineering, Supply Chain, Production, and Quality, ensuring that the Data from the changes created on the PLM system (Agile) was transferred correctly and accurately to the ERP system (Oracle)

in a timely manner. I ensured training was compliant on all Document Control and

QMS areas.

Supported CCB, by ensuring accuracy of the Engineering Change Requests, reviewing design changes, and running Change Integration Board meetings to determine effectivity dates.

IRRAS 2019 – 2020

11975 El Camino Real, Suite 304

San Diego, Calif. 92101

Change Management Analyst

As a Change Management Analyst, I provided direction, coordination, and implementation of changes to configurations for all design documentation for the manufacture of biomedical dual lumen devices and Control Units (CUs) that both supplies and evacuate fluids from the brain cavity due to head traumas.

This involved working closely with Document Control, ensuring that all of the SOPs, Manufacturing Work Instructions, Assy drawings, Product Specifications, and ECO’s were implemented in an effective and expedient manner. Provided training.

Worked closely with Quality & Regulatory departments to maintain control of Design History Files, Device Master Records, Regulatory Technical Files, and assisted in internal audits.

Created the Configuration Control Board, reviewing engineering changes, supplying dispositioning of parts, reviewing design changes, and determining effectivity dates for production.

Worked closely with Contract Manufacturers, Manufacturing Engineering, Quality Control to ensure that the Assembled Device (Controlled Unit) was production ready. Created and maintained MPN’s (Marketing Part Numbers) utilizing Master Control for the Control Units.

Solar Turbines Inc. 2011 – 2019

2200 Harbor Drive

San Diego, Calif. 92101

Document Control Specialist/ Change Administrator

As Change Administrator, I provided direction, coordination, and implementation of changes to configurations for all design documentation for the manufacture of Gas Turbine Engines.

Responsible for providing accurate, comprehensive documentation of turbo machinery enhancements and manufacturing process changes, ensuring that the product families were integrated and documented by maintaining coordination of the cross-functional disciplines by executing the intent of all changes.

Participated in the creation and simplification of configuration and data management (CDM) process activities through information technologies (PLM and ERP) and 6 Sigma/Lean methodologies.

Provided training on CM/DM practices and Windchill PLM. I conducted training courses for subordinate staff, by directing Document Control administrative assistants on various change activities. Created and revised a large volume Bill Of Materials (BOMs) that was translated from Windchill PLM into the Baan ERP system.

ViaSat Inc. 2004 – 2011

6155 El Camino Real

Carlsbad, Calif. 92009-1699

Configuration Management/ Data Management Analyst

Managed hardware and software engineering documentation and data, that produced commercial and military satellite communication systems, working closely with program management, engineering, quality, software, and government personnel.

Point Of Contact for configuration and data management activities for the MIDS LVT and MIDS JTRS military satellite radio programs. working with the International Program Office (IPO) ensuring CDRL deliveries were accurate and on time.

Administered and submitted Engineering Change Proposals (ECPs) within the MIL Standard guidelines to the IPO and other government agencies.

Participated in Technical Working Group meetings hosted by the IPO, representing Configuration Management for ViaSat, solving ECP, Problem Reports, and Deviation issues with the various platforms working with BAE and EuroMIDs.

Managed and chaired all of the electronic change control boards (CCB) for both government programs and commercial programs utilizing Agile PDM tools and implementing and creating BOMs utilizing Oracle based ERP systems, which resulted in efficient and rapid releases.

Axelgaard Manufacturing Co. Ltd 1998 - 2004

520 Industrial way

Fallbrook, Calif. 92028

Documentation Control Analyst

Managed the entire documentation system to facilitate the manufacture of neurostimulation and sensing electrodes and other medical devices.

Maintained and updated standard operating procedures, assembly drawings, validations, specifications, new part number requests, and bills of materials.

Chaired all CRB meetings and implemented the engineering change orders for the company.

Conducted internal audits to ensure FDA certification of Axelgaard’s bio medical devices and products. Successfully received FDA approval from numerous cGMP Audits.

EDUCATION & PROFESSIONAL DEVELOPMENT:

Bachelor’s Degree, Industrial Technology, San Diego State University: May 1991

Product Documentation Control, parts 1 & 2, from the University of Wisconsin

Highly experienced in Windchill PLM, Agile, Master Control, TeamCenter, ORACLE, SAP,

and DOORS.

Other skills include eQMS software programs, 3D Modeling design layout tools,

Pro Engineer, AutoCAD, Microsoft Word, PowerPoint, Excel, Visio, and Adobe.

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