Action-Oriented Documentation Specialist with more than 20yrs. experience and strong ability to communicate effectively with associates and third parties. By working in R&D as an analyst; I developed a mind-set capable of
troubleshooting, problem solving. High-energy President for Soroptimist International of Hackettstown successful in building and motivating
dynamic committees. Cultivate a culture in which members feel
comfortable voicing questions and concerns, as well as contributing new
ideas that drive growth within our club.
Knowledgeable of quality control processes/standards
Microsoft Office proficiency
Hispanic Network Leader03/2004 to 03/2005GlaxoSmithKline CHParsippany, NJ
making sure the Network goals were aligned and would meet the companies'
Organized cultural events strengthening internal cultural awareness of the Latino community
Lead group in providing translations on several corporate brands and surveys from
English to Spanish; specifically oral healthcare brand
Documentation Specialist07/2002 to CurrentGlaxoSmithKline Consumer HealthcareParsippany, NJ
Multitasking by managing multiple inter-departmental activities which are part of projects with aggressive timelines.
Interaction with US R&D; Manufacturing and Contracting sites in order to review, approve, issue, and maintain incoming documentation within compliance and corporate standards.
Create, Review, Approve, Issue and Distribute Specifications within our database systems Documentum and LIMS in adherence to GMP's and corporate policies.
Manage procedure, documents and approvals
required for products produced in the United States to foreign markets in
adherence to corporate policies.
Manage documentation status matrices/databases for tracking projects, and documentation to ensure current status is reflected and information is available for all system users.
Manage Product Manuals for Smoking Control category.
Provide technical advice to R&D, and commercial associates on issues related to documentation as per departmental SOPs
Manage Groups on-line communication collaboration Team Site
Provide backup assistance to other members within departmental team, as needed
Knowledge Management Leader01/1999 to 01/2000SmithKline Beecham Consumer HealthcareParsippany, NJ
Promoted and encouraged Knowledge Management use.
for coordinating training, help plan and develop training program and all
training documentation with Business owners
Central contact for
system users and liaison between IT and R&D.
Assisted in identifying and implementing ways
to improve use and understanding of the system within New Product Development.
the project, maintaining team morale and commitment, ensuring milestones
Team Coordinator01/1994 to 01/1996SmithKline Beecham Consumer HealthcareParsippany, NJ
Leadership role in addition to Associate Scientist role.
Led meetings and planning sessions
demonstrated co-management techniques with
motivated and assured team members were jointly participating in
completing projects, objectives and work schedules.
Associate Scientist01/1991 to 01/2001SmithKline Beecham Consumer HealthcareParsippany, NJ
Organized the planning and performance of analytical methodologies.
Provided formal training to new employees on SOPs, FDA/ICH guidelines and analytical methods.
Operated, calibrated, and repaired
instrumentation (HPLC, UV-VIS
Provided formal Method Transfer training in
Spanish to foreign affiliates in Mexico
Education and Training
Bachelor of Science: BiologyKean University of NJUnion, NJ, USAPresident of Science Organization Club
Project ManagementStevens Institute of TechnologyJersey City, NJ, USAProject Management Certificate
I have been an active member of Soroptimist International. For the past year I have been President of SI of Hackettstown. As President for I have been successful in building and motivating dynamic committees.
I have cultivated a culture in which members feel comfortable voicing questions
and concerns, as well as contributing new ideas that drive growth within our
club. I have led the club through major changes within the current bylaws, and have been slowly implemented minor changes within certain committees.
ERA 2005 GMS Recognition Award
Impact Bronze award for above product project for: "Adapting to new challenges and opportunities, "Customer focus", "Taking initiative and extraordinary effort", and "Measuring and delivering results
Team award from Marketing for: "meeting the accelerated timetable"
Team Player for: "Exceptional Commitment to teamwork and outstanding performance in a group effort"
Fluent in Spanish/English
LIM's and Documentum- proficient
IT packaging documentation systems Falcon, Fluffy-Duck- competent
Global Documentation Group databases; such as, SOP, Export Matrix, Raw Material Index- knowledgeable