Sheila L. López Cabrera
Guayama ,PR
Summary
Hand-on computer system professional offering over 17 years of experience in the medical device and pharmaceutical industries. Audit confidential documents such as manufacturing, packaging and bulk shipment, laboratory results of raw material, vendor certificates and packaging components. Experienced and skilled in Document Management with excellent communication skills with all levels of the organization. Dedicated to overseeing document filing and highly trained in workflow supervision. Bilingual (Spanish and English).
Overview
18
18
years of professional experience
1
1
Certification
Work History
Documents Control Coordinator
Bristol Myers Squibb
Humacao, PR
07.2019 - Current
- Responsible to assure adequate filing, management, and retrieval of site GMP documentation within the Central Documentation Area.
- Accountable for the proper storage and safe-keeping of filed documentation, including retention of documents per BMS established guidelines
- Receive the documentation and enter all data on a timely basis in the Records Management System (RMS)
- Responsible to assign and reconcile BMS Humacao Logbooks.
- Prepare and file GMP documentation annually to send to offsite storage.
- Maintain and updated document control database with new documents, revisions and changes.
- Provide support to all departments that request access to controlled documentation in a regular basis.
- Request documentation from offsite storage when is required.
- Receive, verify, and identify Retain Samples from QC/QA to enter in the Sample Manager System LIMS.
- Perform retain samples physical evaluation.
- Responsible of retain samples disposal from BMS Humacao based on regulatory expiration dates following site quality procedures.
- Responsible of the Retain Sample Room temperature monitoring, including install and remove the chart recorder.
- Support internal and external audits and regulatory inspections.
- Comply with all Security Guidelines, Environmental Health and Safety regulations and current Good Manufacturing Practices required by the function.
- Revised Quality Systems procedures and updated throughout DCA lifecycle until competition.
Documents Control Administrator (consultant)
Bristol Myers Squibb
Humacao, PR
01.2018 - 07.2019
- Lead the project and development of the Document Control Area for BMS Humacao
- Developed and implemented new procedures for the management and controls for the Document Control Area
- Follow RMS (Record Management System) policy and procedures for recording, filling, and retrieving GMP approved documents
- Create physical and electronic record files for the Central Documentation Area
- Designed and implemented 5's program in the Document Control Area.
Documentation Specialist (Knowledge Management Consultant)
Bristol Myers Squibb
Humacao, PR
03.2017 - 12.2017
- Reviewed and edited MBR Reformat Process Simplification Project in both languages (Spanish & English).
- Uploaded procedures and Master batch Records and updated throughout DCA lifecycle until competition.
- Inspected and proofread documents to check accuracy.
- Managed and control effective training records.
- Reviewed procedures for operations area or for equipment to harmonize them with the process reality and operational experiences.
- Updated electronic learning Management system as per DCA changes and training event-recording processes
- Managed a procedure system and assigned an effective date of site SOP in DCA system
- Designed and implemented 5's program for B-18 File Control Area.
Manufacturing Technology Documentation Specialist (Consultant)
Bristol Myers Squibb
Humacao, PR
06.2014 - 05.2016
- Migration of Master Batch Records from hard copy to DCA system
- Master Batch Record revision (Granulation Stage) for Weigh and dispensing project.
- Proofread existing documents for errors in grammar, punctuation, spelling, syntax, formatting.
- Ensure that the effective version was correct before revision
- Review, update and create MBR's as required
- Performed MBR's redlines (hard copy and MS Word)
- Uploaded technical documents and Master batch Records and updated throughout DCA lifecycle.
- Created Master batch Records packages in DCA.
- Obsolete documents when required.
EHS Documentation Specialist (Consultant)
Medtronic
Villalba, PR
12.2013 - 05.2014
- Worked in EHS procedures harmonization Project for MPROC sites (Villalba, Juncos, Humacao)
- Tracked project schedules and encouraged teams to complete tasks on time.
- Organized client meetings to provide project updates.
- Reviewed EHS and Facilities procedures.
- Uploaded procedures for revision using the appropriate format template and updated throughout Agile system lifecycle until competition.
- Performed Procedures Periodic Review
- Run SABA reports for training purposes
- Assisted EHS team in the ISO 14001-OHSAS 18001 re-certification 2014.
QA Specialist I, Record Reviewer
Pfizer Consumer Healthcare
Guayama, PR
05.2011 - 08.2013
- Ensured that the proper documentation of manufacturing and packaging processes was completed according to GMP, company and FDA regulations
- Audited confidential documents such as manufacturing, packaging and bulk shipment, laboratory results of raw material, vendor certificates and packaging components
- Reviewed and approved executed Manufacturing and Packaging Batch Records
- Generated rejection and quarantine notices, labels, and all related documents for hold process
- Performed AQL Inspections to finished product
- (Approved or rejection according to the ANSI/ASQ ZI.4 table)
- Evaluated quality incidents on the shop floor
- Performed and approved preliminary assessment to finished product to quarantine shipment to the distribution centers
- Reviewed Certificate of Analysis (CoA) and temp tale of manufacturing batches from another Pfizer sites
- Evaluated procedures, recommended and submitted changes when necessary
- Provided input on Manufacturing Investigations (MIR) when was required
- Trained new personnel on QA Record Reviewer duties
- Participated actively regulatory inspections and internal company audits
- Performed required queries on SAP/CAPA and Trackwise system to provide evidence of document closing at disposition time
- Coordinated priorities to assure timely release of materials and products
- Assigned and verified dates and /or manufacture retest and expiration dates to raw material, packaging components and finished product
- Prepared, organized and maintained Quality Assurance Released and Rejection Raw Materials and Packaging Components Excel Monthly
- Prepared and filed Manufacturing, Packaging Lot released records to be sent to record retention area
- Recognized for successfully finished product release according to release metrics of the plant.
Product Specifications, Data Coordinator
Pfizer Consumer Healthcare
Guayama, PR
01.2009 - 05.2011
- Typed, Edited, Proofreading, Verified and Approved Master Packaging, Bill of Parameters (BOP) and Manufacturing Batch Records
- Generated commercial and experimental master batch and packaging records for production
- Verified the Master Batch and Packaging Records, Production Orders and BOM's are the same
- Routing Master Batch and Packaging Records for approval
- Prepared, Organized and Maintained the device master record files (electronic and hardcopy files)
- Audited History Versions of Packaging and Manufacturing Batch Records to be sent to Record Retention Area
- Ensure all department documents are correct, efficient, and effective.
- Made MBR's obsolete when required
- Maintained an inventory of supplies items used the Department
- Scanned documents as requested
- Created, verified, and entered inventory material for Pharma and Consumer
- Participating in FDA, Invima and internal audits.
QA Specialist I, Record Reviewer
Wyeth Consumer Healthcare
Guayama, PR
05.2007 - 12.2008
- QA Specialist I, Record Reviewer
Product Specifications, General Documentation Clerk
Wyeth Consumer Healthcare
Guayama, PR
08.2006 - 05.2007
- Product Specifications, General Documentation Clerk
Education
Bachelor's Degree in Computer Science -
Interamerican University of Puerto Rico
Ponce, Puerto Rico01.2006
Associate's Degree in Information Systems -
Technical Institute of Puerto Rico
Guayama, Puerto Rico01.2003
Skills
- Strong Knowledge: SAP, SQLLIMS, SMS-SQ; LABWARE, TRACKWISE, TIMS; PLATEAU; GX PHARMA, NOVAMANAGE, ELIS, MBRIT (Master Manufacturing Record Impression Tool), MES QA (Manufacturing Electronic System), Safety and Lean Manufacturing (5's); PDOCS, ANSI/ASQ ZI4, GMP (Good Manufacturing Practice), IQMS Document Control System, Agile - Product Lifecycle Management, Document Control Archiving (DCA), Adobe Professional, SuccessFactors (ELMS), Pedagogue, Record Management System (RMS); Multiple Inventory Control System (MICS); Laboratory Information Management System (LIMS)
- Extremely organized and resourceful
- Able to learn quickly
- Ability to work with minimal supervision and under pressure
- Excellent interpersonal and communication skills
- Strong knowledge on SAP WM and QA modules
- Teamwork, persistent, punctual, and determinate
- Strong leadership skills able to direct and make decisions
- Knowledge and vast experience on Technical Writing, Document Management, Information retention policies, Process Improvements
- Strong Knowledge in Microsoft Office Programs (Outlook, Word, Excel, Power Point, Access) Programming Systems (Visual Basic, C), Internet Explorer
- Bilingual (Spanish & English)
Accomplishments
- 2023 Nominated as Compliance Most Value Employee
- 2022 Quality Operations Empleado Simbolo
- 5S Compliance Area Leader
- 2011 Record Reduction Accomplishment
- 2011 Quality Operations Most Colleague
Certification
- Train of Trainer Certification
- Tablets Defect Identification in Retain Samples Certification
Timeline
Documents Control Coordinator
Bristol Myers Squibb
07.2019 - Current
Documents Control Administrator (consultant)
Bristol Myers Squibb
01.2018 - 07.2019
Documentation Specialist (Knowledge Management Consultant)
Bristol Myers Squibb
03.2017 - 12.2017
Manufacturing Technology Documentation Specialist (Consultant)
Bristol Myers Squibb
06.2014 - 05.2016
EHS Documentation Specialist (Consultant)
Medtronic
12.2013 - 05.2014
QA Specialist I, Record Reviewer
Pfizer Consumer Healthcare
05.2011 - 08.2013
Product Specifications, Data Coordinator
Pfizer Consumer Healthcare
01.2009 - 05.2011
QA Specialist I, Record Reviewer
Wyeth Consumer Healthcare
05.2007 - 12.2008
Product Specifications, General Documentation Clerk
Wyeth Consumer Healthcare
08.2006 - 05.2007
Bachelor's Degree in Computer Science -
Interamerican University of Puerto Rico
Associate's Degree in Information Systems -
Technical Institute of Puerto Rico
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