AREAS OF EXPERTISE:

• cGMP Critical Drawings
• Engineering TOP’s
• MCSA Cert.
• Box
• AutoCAD Cert.
• SharePoint
• Buzzsaw
• MS Office eDoc
• Construction TOP’s
• Vendor TOP’s
• Adobe Acrobat Pro.

PROFESSIONAL EXPERIENCE:

Document Control Manager

Confidential, Covington, GA

Responsibilities:

• Manage 300+ engineering and construction turnover packages, for a $400 Million dollar project.
• Responsible for the completion and sign - off stages of all turnover packages.
• Manage a team of five document control specialists.
• Work hand-in-hand with the Vice President of Confidential and Commissioning Manager of Baxalta, to ensure quality control on timely delivery of all packages and requirements.
• Serve as a liaison with the engineering and construction staff, to resolve issues regarding submittals, drawings, specifications and field documents.

Document Control Manager/Engineering Assistant

Confidential, Swiftwater, PA

Responsibilities:

• Maintained paper and electronic documentation generated by all internal and external engineering resources contributing to design, construction, qualification and validation of the site-wide utility system.
• Designed a cataloging and retrieval system to maintain all project documentation and identify remaining gaps requiring resolution.
• Managed and reviewed the “As-Builts” between the subcontractors and the design/engineering firm, to ensure that all redlines have been captured and incorporated into the final drawings and documents.
• Maintained the historical basis of all work performed on the project to ensure that when work is completed, a proper audit trail will exist for regulatory approval.
• Tracked the Preventive Maintenance activities and finalized the preparation of the equipment tracking to ensure all activities were documented to support warranty requirements as well as quality integrity.

Document Control Manager/Engineering Assistant

Confidential, Swiftwater, PA

Responsibilities:

• Work hand-in-hand with the project Engineering Director to ensure quality control on timely delivery of all packages and requirements.
• Ensured required documentation will be fully controlled and accurately reflect “as built” status.
• Ensured the electronic document system will be capable of fully supporting the ongoing engineering and operational requirements of the facility when completed.
• Served as the key liaison for all document users to facilitate full accessibility to all information required for the successful control and completion of the project.
• Managed the logistics of all equipment either new or reused to and from the warehouse and ensured that the equipment is maintained during the storage phase.
• Successfully turned over the entire project library to final repository in a well tracked and organized manner.

Document Control Manager

Confidential, Swiftwater, PA

Responsibilities:

• Work hand-in-hand with the project Engineering Director to ensure quality control on timely delivery of all packages and requirements.
• Managed 4 Document Control rooms and a team of 8 individuals.
• Developed SOPs for the project regarding Project Turnover from the Confidential to the Client.
• Successfully turned over the entire project library to final repository in a well tracked and organized manner.

Document Control Lead

Confidential, Swiftwater, PA

Responsibilities:

• Liaison for Quality Assurance, Technical Services and Site Services between the Construction Manager, vendors and contractors.
• Developed, assembled and transferred engineering documentation required for validation to Technical Services.
• Facilitated weekly meetings with the Construction Manager and resolved validation issues regarding incomplete documentation needed for the close out of systems.
• Organized, maintained and supervised the entire document library for the project.
• Provided the Maintenance department with critical information such as: part numbers and serial numbers for various equipment and instrumentation on utility systems.
• Maintained, assembled and updated Engineering Turnover Packages and Operating/Maintenance manuals.
• Integrated the engineering and validation efforts by teaming up with the Project Engineers, Construction Manager, Validation Manager and Validation Specialists.
• Provided record drawings to the engineering group to ensure cGMP updates as needed.

Confidential

Confidential Applications Engineering Specialist, Clinton, NJ

Responsibilities:

• Supervised the server support team; for the Confidential project servers.
• Administered and supervised a Windows 2000 (active directory) domain and four Windows NT domains for a large engineering firm with several contracts of over 250 million dollars on the systems that I managed.
• Created and modified local and domain user accounts; including roaming and mandatory network profiles and network policies for Windows 2000 and Windows NT domains, for an entire division.
• Executed company backups, restores and archives; using Veritas Backup Exec 8.6.
• Migrated data, programs and software licenses from Windows NT domains, Windows 95 and Novell platforms over to our new Windows 2000 active directory domain.