Connie Collins
Lake Charles
Summary
Dynamic Document Control Specialist with extensive experience, excelling in quality assurance and change management. Proven track record in optimizing document processes and enhancing compliance. Proficient in SAP and Open Text, leveraging strong analytical skills to drive efficiency and accuracy in documentation across diverse industries, including pharmaceuticals and renewable energy.
Overview
13
13
years of professional experience
Work History
SR. DOCUMENT CONTROL COORDINATOR
Abiomed, Inc./Johnson & Johnson Med Tech
Danvers
01.2023 - Current
- Process Engineering Change Orders using defined processes - This includes changes to Forms, redlines, drawings, manufacturing inspection, assembly procedures, IFUs, labels, flowcharts, travelers, document Metadata etc., as well as implementing the Updates to Bill of Materials, Creation of BOMs, Equipment Changes, Design Changes, Material Changes, Inspection Plans, Work Instructions & SOPs
- Manage the change control system; review, problem solve, route, assess training impact and release change orders.
- Assist users in assuring that all Change Order packets are accurate and complete
- Support scanning, archival and retrieval of quality documents and records.
- Manage standards in accordance with standard operating procedures.
- Maintain a state of compliance with international quality standards, work with other departments to maintain the global records systems and change order processes
- Support in identifying process improvements to improve the efficiency and compliance of global documentation and record retention systems
- Support development/ improvement activities associated with SAP system and PLM systems
- Trusted to complete high risk and fast paced documentation related to CAPA (Corrective and Preventative Actions), MCAP (Management Corrective Action Plan), and FDA (Food and Drug Administration) tasks
- Create, manage, and audit Bills of Materials (BOMs), ensuring completeness, accuracy, and manufacturability.
- Collaborate closely with Engineering and Manufacturing teams to ensure accuracy and facilitate smooth transition to manufacturing.
- Establish and enforce processes for revision control, change management, and approval workflows for all Change Request documentation.
PACKAGE DATA ANALYST
3M Packaging Solutions
St. Paul
11.2021 - 09.2023
- Enter Package Levels, Shipping & Handling & Article Numbers in GGSM (Global Goods/Service Management)
- Cross reference IPM (Integrated Package Management) and correct data to match
- Develop new reports as needed/requested by management to provide timely and accurate information to decision makers
- Identify problematic data areas and conduct research to determine options for resolution
- Responsible for analysis, solution definition, technical recommendation, and testing of the upgrade of each system used for reporting and perform gap analysis for changes to current reports, also test and validate the upgraded system and reports
DOCUMENT CONTROL SPECIALIST
Infineon Technologies - IR HiRel
San Jose
05.2021 - 09.2021
- Assist in preparation and review of Engineering Change Orders, Kitting documentation, Work orders, digital drawings, Modification Authorization forms, & etc
- Assist in the preparation and generation of new documents, specifications, and procedures
- Compilation and maintenance of document control records and related files to release and / or change specifications, drawings, procedures, and engineering documents to manufacturing and other operating departments
- Data entry and maintenance of master data information into SAP system, Waypoint, Auto CAD and others
- Maintaining the control and integrity of the shared Server for manufacturing doc packages, documents and specifications used in the manufacturing of products at subcontractor sites
DOCUMENTS MANAGER
Vineyard Wind / Park City Wind - Renewable Energy
Boston
06.2020 - 04.2021
- Coordinate and manage access and permission rights to the EDMS
- Quality check internal documents as well as External Provider documentation
- External deliverable documents shall have a project specific front cover attached
- Maintaining the Package (Master Document Registers) MDRs
- Monitor and issue (External Provider Document Register) SDRs to all External Providers
- Documents are issued in a controlled manner via a Document Transmittal Notice (DTN)
- Distribute external documents to the package teams
- Create & Review Invitation to Tender (ITT) documents before being issued
- Manage and coordinate External Providers and the Project's Final Documentation with the assistance of the department heads
SR. COMMISSIONING DOCUMENT CONTROL SPECIALIST
Sasol North America - Chemical/Oil & Gas
Lake Charles
03.2016 - 04.2020
- Management of commissioning documentation for the LDPE, Ethylene, Alcohol II, ETO (Alcohol Ethylates), UOI and Guerbet alcohol plants within the LCCP Mega projects
- Controlling documentation for over 500 Commissioning systems
- Retrieve and edit templates as requested on the System File Index to build an electronic system file package in Open Text & audit equipment documentation for completeness per commissioning guidelines
- Support document control related activities such as the formatting and routing of procedural documents
- Train Commissioning Team members on Document Control processes and procedures
PSM DOCUMENT REVIEW & COLLECTION
Southern Company
Birmingham
08.2015 - 02.2016
- Responsible for collection and review of documentation for the chemical process portion of the Kemper Power Plant for rotating equipment, pressure vessels, electrical instruments, control valves, hand valves and atmospheric tanks to include; MTR's, PMI, drawings, P&ID's, MDR's, bench tests, design specifications, vendor data, design calculations, pressure tests, stress relief reports, NDE's, WPS's, U-1 Forms, Photo Nameplates.
- Assure compliance with policy & procedure by retrieving and reviewing documentation to assure accuracy and quality.
- Ensure consistent application of standard document management tools, processes and systems to maintain integrity of technical documentation including all engineering, vendor and construction documents.
- Provide technical services as necessary to ensure technical documentation accurately reflects the site and equipment conditions in support of project execution.
- Train new team members on documentation collection, review and set up new items in the SharePoint tracking system.
DOCUMENT CONTROL SPECIALIST
Robins & Morton Power & Industrial, LEPA
Morgan City
08.2014 - 08.2015
LEAD DOCUMENT CONTROL SPECIALIST
Shaw Group/Chicago Bridge & Iron - Nuclear
Lake Charles
03.2012 - 06.2014
Education
Northwest Arkansas Community College
01.2006
Skills
- Documentum
- EDMS
- MC Plus
- Open Text
- SAP
- SharePoint
- Tableau
- Waypoint Global
- Project Web Collaboration (PWC)
- SmartPlant
- Omega PIMs
- MS Office Pro
- MS Visio
- Adobe Pro
- Auto CAD
- IPM (Integrated Package Management)
- GGSM (Global Goods Service Management)
- MICAW (Material Information Collection and Workflow)
- Doc Management
- Packaging Analyst
Timeline
SR. DOCUMENT CONTROL COORDINATOR
Abiomed, Inc./Johnson & Johnson Med Tech
01.2023 - Current
PACKAGE DATA ANALYST
3M Packaging Solutions
11.2021 - 09.2023
DOCUMENT CONTROL SPECIALIST
Infineon Technologies - IR HiRel
05.2021 - 09.2021
DOCUMENTS MANAGER
Vineyard Wind / Park City Wind - Renewable Energy
06.2020 - 04.2021
SR. COMMISSIONING DOCUMENT CONTROL SPECIALIST
Sasol North America - Chemical/Oil & Gas
03.2016 - 04.2020
PSM DOCUMENT REVIEW & COLLECTION
Southern Company
08.2015 - 02.2016
DOCUMENT CONTROL SPECIALIST
Robins & Morton Power & Industrial, LEPA
08.2014 - 08.2015
LEAD DOCUMENT CONTROL SPECIALIST
Shaw Group/Chicago Bridge & Iron - Nuclear
03.2012 - 06.2014
Northwest Arkansas Community College