A H IGHLY MOTIVATED, EXPERIENCED PROFESSIONAL WITH SKILLS IN QUALITY ASSURANCE, QUALITY
C ONTROL, EDUCATION AND OFFICE ADMINISTRATION
S KILLS
Bilingual
•
( Spanish)
Advanced
•
C omputer Skills
HR Skills
•
Executive
•
A ssistant
Travel
•
A rrangements
OSHA
•
FDA
•
GMP
•
GDP
•
HIPPA
•
ISO 13485:2003
•
Radiation Safety
•
B renda L. Miller P age 2
EXPERIENCE
Quality Coordinator ( Short Assignment)
0 6/14-
DNP- Concord, NC
Track Customer complaints and CAPA.
•
First Article Inspections.
•
Inspected products to determine disposition.
•
Inspected products to verify meets product specifications.
•
Write and edit Work Instructions and SOP.
•
QUALITY ASSURANCE DOCUMENT CONTROLLER & TRAINING COORDINAT
Eckert & Ziegler, BEBIG, Inc. -
1 0/11 / 03/14
Electronically management, coordination, implementation, control and
•
o f Quality System this include: Standard Operation Procedures, W
Forms.
Approve, review and update documents; make changes and identify re
•
document distribution; and prevent use of obsolete documents, facilitati
Issued controlled unique reference numbers to support relevant QMS ac
•
Processed Batch Records, Validation Documents, Miscellaneous R
•
Specifications.
Tracking and update logs for: Training Matrix, Training Plan, em
•
descriptions, CAPA system, non-conforming, change control, comp
product release.
Collected, analyzed data from test results, generated regular repo
•
updated all quality data, license and manual books.
Supported Internal, External Quality Auditors., followed FDA, NR
•
regulations.
Assisted in the preparation of Technical Files, DMR, PFMEA and flow
•
c lerical, e-mails, preparing labels, mailing, customer service and faxing.
QUALITY CONTROL COORDINATOR
Visual inspection of medical devices packaging surfaces and packaging
•
and free of obvious cosmetic defects.
Inspection of labels applied in order to maintain traceability during steril
•
Review of traveler documents to ensure accuracy of quantity, rev
•
specifications.
Verify the presence and location of required medical devices, accord
•
product documentation (drawing, assembly procedures, and radiograph)
Process medical devices reject, mark the locations of observe defect
•
and segregate nonconforming medical device to Material Review Board
Manufacturing Engineering and Quality Director.
ACCOMPLISHMENTS
D irectly responsible for creating, distributing and performing training verific
procedures, work instructions and forms. Interfaced regularly with the UK Quality
r ecommended document control system improvements. Met all corporate timelines
resulted in our company being one of the first to implement the Quality System
d uring monthly worldwide company presentations.
0 8/08 -10/11
ADMINISTRATIVE ASSISTANT
Yale Behavioral Health Services - Hamden, CT
Filled and updated medical records for treatment plans and assists in ph
•
Reviewed outgoing material to ensure attachments, dates, and signatu
•
accurate.
Assembled and maintained current charts and provides clerical/ad
•
including the composition and preparation of routine correspondence.
Completes a broad variety of administrative tasks including: managing
•
calendar of appointments; composing and preparing correspondence.
B renda L. Miller P age 2
QUALITY INSPECTOR SUPERVISOR 1 0/04 – 02/08
American Plastic Products- Waterbury, CT
Determined that all units contained corresponding kits and were cosmetically free of defects prior to
•
p acking.
Inspected assembled products ready to ship to conform that they met company standards and customer
•
s pecifications. Mentored teams to analyze the quality of the products assembled.
Performed production/packaging start-up and continuous monitoring of the line operation.
•
Assigned line workers to their position on the line and provide instructions as required.
•
Monitored component requirements and delivered materials to line as needed.
•
Rotated workers, and directed and led line operation to assure production goals were achieved.
•
TEACHER ASSISTANT 0 8/01 – 05/02
Department of Education - Moca, PR
Designed and planned daily lessons for a class of 30 students, and enforced administration policies and
•
r ules governing students.
Observed students' performance and recorded relevant data to assess their progress and facilitated
•
r egular parent conferences.
LEGAL SECRETARY 0 8/97 – 06/99
Luis A. Loperena, Lawyer Buffet -, Moca, PR
Conserves attorney’s time by reading, researching, reviewing, verifying, and routing correspondence,
•
r eports and legal documents.
Drafting documents; collects evidences, initiating telecommunications and manage lawyer calendar.
•
Organize and maintain law libraries, documents, and case files.
•
EDUCATION
Master of Public Administration ● Health Services 6 s emester hours 0 6/11
K eller Graduate School of Management
Bachelor of Science ● Business Administration/Management 0 5/10
University of Phoenix
B achelor of Science ● Natural Sciences 115 semester hours 12/02
University of Puerto Rico