Quality Control Management

Libermarie Gonz lez N ez

Caguas Real Home Resort

*** ******, ** *****

Cel.787-***-****

Objective To obtain an innovative position in a competitive organization

where I can apply my skills to contribute to the interests and

growth of the company.

Education 2000 - 2001 Interamerican University, Metropolitan Campus

Medical Technology

1996 - 2000 University of Puerto Rico, Arecibo Campus

B.S Microbiology Sciences

Professiona Pfizer / Wyeth CHC Guayama Aug 2006 - Present

l

Experience

Engineering & Technical Services, Technical Scientist IV

Responsible for moderately complex projects related to the

development or application of state of the art process, equipment

control, and standards process optimization, qualification or

transfers of product. Resolves moderately complex process issues,

diagnostic's technical problems and identifying short-and-long term

solutions.

Accomplish validation tasks on small to large projects

independently, performing validation projects of more technical

complex nature on cGMP equipment systems and processes that include

authoring protocols, executing validation protocols and writing

reports of validation results. Represents the validation

engineering department to contribute to Validation Master Planning

on specific projects. Responsible for develops validation

schedules, resource loading, and others project deliverables.

Ensures timely resolution of all deviations and changes that occur

during the execution phase. Lead the validation activities for

medium to large scale projects. Representing the validation

department on cross functional site teams. Review and approve

validation protocols and summary reports generated by validation

staff. Contributes in developing validation best practices,

standards, and guidelines, which includes exploring new techniques,

methods, and other industry practices.

PACIV, INC May 2004 - Aug 2006

Validation Specialist II & QC/QA Representative

Responsible for the development, review and execution of CSV

Validation/Qualification Activities for the Delta V system at the

New Humalog Facility at Lilly del Caribe. Support all technical

writing, CAPAs, development, and execution of protocols.

Responsible for all document-handling duties. Develop CSV

documents, incorporate revision comment, and documentation

management.

PACIV Quality Reviewer of executed Delta V CSV Packages

QC and QA Representative for all projects in PR and USA. Internal

and External audits. Audits for the GMP documentation being

developed and executed by associates or Contracted external

resources. Responsible for update all corporate quality policies

and procedures. Act as liaison between QC representatives of the

client and associates.

Schering-Plough LLC. Apr 2002 ( May 2004

Manat , P.R.

Technical Services Validation Specialist I

Writing, revision and execution of process validation activities

(e.g. Validation Memos, Process Assessment, Process Definition and

Validation Protocols) for all products at the API Plant as part of

the Validation Certification Program (Consent Decree).

Historical Data Studies for the determination of holding times,

critical process parameters and critical quality control attributes

for each product under validation project plan.

Coordination and leading of multi disciplinary validation

activities. Provide support, coordination and expertise in the

design, development, execution and monitoring, of validation

activities of equipment, and facilities in alignment with local

requirements and regulations to assure delivery of projects.

Responsible for create and revise procedures as well as generate

investigations, changes, and protocols.

Preparation of final Validation Packages Reports for Quality

Review. (Certification Program)

Pfizer Pharmaceuticals 2002

Barceloneta, PR

Chemical Laboratory Technician

Performance of several Chemical standard tests procedures for

intermediate and final products. Management of chemical laboratory

equipment (class VP Client Server, Karl Fisher, TLC, HPLC, U.V.,

I.R., pH meter, L.O.D. and others). Reads and interprets

analytical tests results.

DEPARTMENT OF EDUCATION 2002

Santiago R. Palmer School

Camuy, PR

Secondary Level Teacher

Social Studies teaching classes.

Professiona Dr. Center Hospital & Dr. 2001 - 2002

l Susoni Hospital Blood Bank

Experience & Clinic Laboratory

Medical Technology Services. Performance of Clinic Laboratory

Analysis. Management of clinical laboratory equipment. Reads and

interprets laboratory analysis results.

Special Caparra Reference 2000

Projects Laboratory Guaynabo, PR

Clinical Practice. Performance at all areas of the Clinic

Laboratory Analysis. Management of clinical laboratory equipment.

Reads and interprets laboratory analysis results.

Skills Fully Bilingual English & Spanish

Knowledge of Pharmaceutical Regulations (cGMP, FDA Regulations and

others)

Technical knowledge in manufacturing validation activities and CSV

life cycle.

Excellent technical writing skills.

Computer Applications: Windows, Microsoft Project, Office, Visio,

and others.

Excellent interpersonal relations, teamwork, leadership,

self-motivation and initiative.

Results oriented.

Ability to work under pressure and with minimum supervision.

Knowledge of the medical, healthcare, and pharmacy industry.

Demonstrated effective organizational and communication skills.

Ability to learn, analyze, understand and convey complex

information.

A valid driver's license and safe driving record.

References Available upon request.

Contact this candidate