Luis Colón Email & Phone Number

Philadelphia, PA, US

Greater Philadelphia

Greater Philadelphia

Malvern, PA

Bridgewater, NJ

Batch Record Initiative

Spring House, Pennsylvania

QA Contractor

West Chester, PA

• Create, revise, maintain and control Corrective and Preventive Action (CAPA) Proof Books in preparation of QHUB, FDA and Johnson & Johnson Audits.
• Manage Change Control system to ensure that no unnecessary changes are made to a product or system, that all changes are documented, that services are not unnecessarily disrupted and that resources are used efficiently.
• Author and update Procedures pertaining to Documentation, such as “Control of Documents” and “Transfer, Storage and Retention of Records.”
• Support Compliance Auditors with various tasks, such as reviewing Objective Evidence, scanning Verifications and uploading them into databases, printing and copying CAPA information and filing documents into binders.
• Track documents regularly and in a timely manner to ensure that only the most current information is available.
• Train CAPA Owners how to navigate through CAPA Proof Books prior to each Audit.

Plainsboro, NJ

• Implemented and controlled the Corporate Document Management System (CDM) as a paper and electronic read-only system; visible on the terminal server for all facilities.
• Administrated the Document Control SharePoint websites and web parts, user roles and securities.
• Prepared and reviewed SOP’s and ensured the submitted corporate procedures met the requirements of Integra LifeSciences document control processes.
• Assured that all documents were appropriately reviewed and approved prior to implementation via change control process and interfacing with SME’s to answer inquiries.
• Generated and published metrics and reports related to the quality system.
• Maintained history files of SOPs, Forms and other controlled documents in strict compliance to departmental policies, regulations and standards and provide notification to all sites of documentation updates

Plainsboro, NJ, 08536

• Manage company records
• General litigation support
• Coordinate destruction of records based on local retentions outlined in Document Catalogue for legal compliance and litigation preparation.
• Reform asset collection process in collaboration with IT, and HR to satisfy current and future tracking metrics
• Oversee and respond to daily requests through Records Management inquiry system.

Princeton, NJ

• Local Records Manager (Contract) at Novo Nordisk A/S
• Assist with operations of the local file room
• Input information into the records management database (OmniRim)
• Coordinate box and or file storage and retrieval from offsite storage vendor (Iron Mountain)
• Manage Laptop Retrieval for LPQ Satisfaction and Track in Atlas for Legal Hold automation
• Spearhead File Disposition Initiative for compliance with local retention schedules

Greater Philadelphia Area

• Batch Record Creation and Revision for Manufacturing with guidance from required departments
• Review all Labeling for Quality and Accuracy with associated departments
• Manage, Create, Revise, Proof, Control, and Release of SOP’s, Change Controls, Investigations, Non-Conformances, for Quality and Regulatory functions
• Perform Internal Audits for cGMP
• Maintain All Records for Quality Department

• Coordinate efforts for the control of new and updated Quality System Procedures for ISO/QSR
• Manage, Update(Edit/Proof read), Control, and Release of SOP’s, ECO’s, ECN’s, Validation Records, Design Control documents, and DHR’s
• Implement and manage the Microsoft Sharepoint system at the 105 Manufacturing Facility
• Requisitioning through Oracle, and updating various metrics tables and charts in Microsoft Excel
• Control International Standards, and Scribe Audits Performed at the Integra 105 facility, Quality Control work for internal audit preparations.
• Knowledge of document retention systems including, but not limited to, Documentum

• Assured the quality and completion of documents required supporting regulatory submissions, following the eCTD guidelines for FDA, actuated through Adobe Acrobat Standard
• Proof read and formatted 1000+ paged documents for FDA and Notified Body Submissions
• With limited supervision coordinated the preparation of European Design Dossiers, PMA Supplements, and 510(k) submissions to global regulatory authorities
• Maintained regulatory database and documents for archiving
• As member of the Regulatory team, interacted with various departments to provide guidance on assigned products/projects

Mount Laurel, NJ

• Packaged First, Second, and Heloc Loans
• Handled and obtained confidential documents including but not limited to Credit reports, Declaration of Conformity, Appraisals, Identification forms
• Appropriated and organized files
• Performed Audit Preperation
• Liaison for all Secondary Loan Department documentation
• Performed clerical tasks including, but not limited to, data entry

Liberal Arts And Sciences/Liberal Studies

Diploma