Technician Management

L ucila Chardon

**** ***** ******** **., ******* NC 27604, Tel: 787-***-****, ******************@*****.***

OBJECTIVE

To obtain a challenging job in a progressive and successful position were my skills and knowledge can be

used to reach the Company goals and to allow me the oppor tuni ty for professional growth and

development.

EXPERIENCE

2/1/2012 to 9/1/2012 BD Biosciences (ACT-1) Cayey, P.R.

QA Technician

• Responsible for the inspection and t imely disposition of raw material, packaging components

a nd Buffer solution preparations using var ious measuring inst ruments, following approved

p rocedures and specifications to determine compliance. Documented inspections performed in

SAP system and required forms as applicable to in a t imely manner.

• Assure that Non Conformance Reports for non-conforming materials were created,

i nvestigated, completed and closed in accordance with the established Standard Operation

P rocedures.

• Performed l ine clearances reviews in a t imely and effective manner as per SOP’s.

• P rovided information for the preparation of the Quali ty Met r ics repor t in a periodic basis as

per established procedures.

• K eep abreast of the basic requirements for compliance in own area of work and complies wi th

t hose requirements. Par ticipated as required in t rainings on regulatory issues affecting own

a rea of work. Brought regulatory compliance questions/issues to the attention of management.

• Part icipated actively in the daily Management System by attending shift star t-up meetings

a nd providing met r ics.

• P rovided recommendations to suppor t systems that continuously improve product/process

q uali ty and product availabili ty, reduce costs and increase production capability.

•

12/1/2006 to 9/1/2011 Pfizer Pharmaceuticals Guayama, P.R.

Stability Specialist

• Responsible to provide in a t imely manner Stabili ty and Technology samples to laboratory for

t esting according to schedules.

• P lot and presentation of the Stabili ty metr ic status.

• P repared the schedules for the Stabili ty and Technology samples to be analyzed. Assured that

a ll samples were tested and reviewed on t ime.

• Managed sample results obtained from the lab to be fi led upon documented as per established

p rocedures.

• Prepared the New D rug Application (NDA) and the Annual Product Review (APR) for the

S tability and Retain samples cont r ibutions.

• M aintained the Environmental Stabili ty Chambers area and Retain Samples rooms in

optimum performance. Made notifications for work orders in the area whenever an excursion

occurred.

• Performed physical inspections to retain samples to support complaints received.

•

10/1/2004 to 12/1/2006 Wyeth Pharmaceuticals (Kelly) Guayama, P.R.

Laboratory Analyst

• Analysis of Stabili ty samples and Technology Transfer of solid doses.

• Suppor ted Stabili ty Scientists in the documentation and preparation of the NDA and APR

r eports.

• Experience working with Waters Alliance HP LC, Smiths Ionscan-LS, TA Differential Scanning

Calorimeter and Perking Elmer UV Spectrophotometer.

•

•

•

8/1/2001 to 10/1/2004 L iceo Ponceño Ponce, P.R.

Chemist ry and biology teacher

• Chemistry and Biology teacher

• Scientific Fair Adult Sponsor

• Laboratory delegate

EDUCATION

Pontifical Catholic University of P.R. Ponce

M A Y 2001

Bachelor in Science

• Major in Chemist ry

• Second major in Secondary Education in Chemistry

SKILLS

• Bi lingual (Spanish/English)

• Knowledge i n laboratory equipment and software such as Labware L I MS, SQL L I MS,

T u rbochrom and Empower Data Acquisit ion Computer System.

• Measuring instruments k nowledge such as metr ic r u ler and caliper.

• Computer l i terate w ith knowledge i n softwares such as T rackw ise, SAP, S-PLUS, GX-Pharma

a nd MS Word Excel, Power Point and I n ternet.

• Knowledge of the Pharmaceuticals I ndustry and Medical Devices practices and procedures;

F DA regulat ions, ISO 13485, SOP’s, cGMP’s and cGLP’s.

• Team work oriented and self-motivated.

• Excellent in terpersonal relations and commun ications w ith al l levels of organization.

•

REFERENCES

References are available on request.

Contact this candidate