1. MARÍA DE LOS A. MORALES CRUZ
Brisas del Prado 611 Calle Tiber, Juncos, PR 00777-9416
787-733-5619 (home) 787-485-0869 (mobile)
mariangiemorales@gmail.com
SUMMARY OF QUALIFICATIONS
Service-minded, dependable, and hard working Incoming Quality Assurance Associate
with more than 10 years of experience in the Biotechnology and the medical device
industries. Competent and reliable professional, committed to top quality work. Working
knowledge in receiving, sampling and inspection of bulks products, Laboratory Information
Management System, AQL’s and cGMP’s. Knowledgeable in programs within Microsoft
Office Standard. Bilingual: English and Spanish
EMPLOYMENT HISTORY
AMGEN Manufacturing Limited – Juncos, PR 2004-2014
Senior Incoming Quality Assurance Associate (2009-2014)
Performed sampling applying AQL’s and visual inspection of drug products
Reviewed of batch record elements (e.g. Supplier’s transportation checklist,
Supplier’s COA, transportation temperature data readings) and identification of
discrepancies to complied with the process specifications and cGMP’s
Performed of SAP transactions for inventory movement and adjustment
Assisted in Compliance Investigations
Participated in the manufacturing daily meetings
Coordinated and kept tracking of the samples to be shipped and tested by outside
contract laboratories
Coordinated the samples result entry in the Quality Control Laboratory Information
Management System (QC LIMS) for the Certificate of Analysis (COA) issuance
Provided support and troubleshooting of QC LIMS template and COA’s issues
Provided training and system access to new QA associates in QC LIMS
Logged batch samples in the QC LIMS for the sampling process for raw material,
Component and Bulk Area
ACCOMPLISHMENTS
Successfully trained 4 associates in QC LIMS resulting in an increase of 20% of
resourceful manpower in the use of the system
Participated in the qualification of the launching of various new products increasing
the pipeline of products that reaching millions of patients
Incoming Quality Assurance Associate (2005-2009)
Reviewed raw materials, drug substances and drug products documentation to
complied with the specifications
Performed samples logging and issued COA’s for all Incoming material
2. MARÍA DE LOS A. MORALES CRUZ
Collected drug substance samples and delivered to the appropriate QC laboratories
Sampled and inspected bulk drug product
ADECCO Temporary Services (2004-2005)
(Temporary Contract Employee assigned to Amgen Manufacturing Ltd)
Document Control Coordinator for all manufacturing areas
Assigned to update the Manufacturing Procedures (MP’s) and applicable forms
Coordinated documents (MP’s and forms) routing for revision approval and
implementation
ETHICON, INC – JOHNSON & JOHNSON - San Lorenzo, PR 1989 -2003
Quality Systems Assistant (1998 – 2003)
Maintained and supported various Quality Systems (Operator Certification
Program, Document Management System, Complaint Handling and Tracking
System, and Laboratory Information Management System)
Coordinated and participated in the validation and implementation of the Laboratory
Information Management System.
Provided training and system access to site users.
Monitored system function for troubleshooting
Maintained system tables.
Generated and provided reports for management decisions.
Accomplishments:
Received the Bronze Award for the successfully coordination and implementation
of the Ethicon Quality Information Management System
Received the Rainbow Award for the protocol verification of the computerized
systems to comply with Y2K.
Senior Quality Assurance Technician (1996 – 1998)
Quality Assurance Technician (1992 – 1996)
Manufacturing Operator (1989 – 1992)
EDUCATION
INTERAMERICAN UNIVERSITY OF PUERTO RICO - Río Piedras campus
Bachelor of Science in Computer Science
UNIVERSITY OF PUERTO RICO - Humacao campus
Credit towards a degree in General studies
TRAINING AND SEMINARS
Good Manufacturing Documentation Practices
Operational Excellence
Quality Inspector Certification Program for FDA Regulated Industries
