Quality Technician

Daisy Vinas-Smith

*** *. ************ ***. 224-***-****

Waukegan, IL. 60085 *****.******@*****.***

____________________________________________________________

SUMMARY OF QUALIFICATIONS

• Over 10 years of extensive experience in Clinical and Pharmaceutical,

Microbiology Laboratory.

• In-depth knowledge of Quality processes. Established reputation in integrating

both a proven process orientation and emphasis on consistency and quality.

• Team oriented with excellent interpersonal and communication skills.

Work Experience

Abbott Laboratories – Contract employee 2011 - Current

Quality Engineer, Global Pharmaceutical Research Development Division

• Review/approve batch record packets and associated documentation.

• Assure compliance to Pharmaceutical Regulations and Good Manufacturing Practices,

support manufacturing areas by performing in-process QA checks, sampling, and other

related activities, and provide quality approvals in materials management system as

defined by procedures.

• Review/approve clinical documentation and specifications, as applicable, write/review

policies/processes/procedures and related documents, assist in the preparation of audits

conducted by regulatory agencies, customers, internal groups.

• Participate with support groups in developing/prioritizing QA activity timelines.

• Actively monitor the effectiveness of processes and quality of project work with

management, and propose and execute quality/process improvements.

Abbott Laboratories - Lake County, IL. 2000 - 2011

Senior Quality Technician. Abbott Diagnostics Division

• Performed Microbial testing using Membrane Filtration, Streak Plate, and Pour

Plate Method. Performed Gram Staining, and Microbial identification per

Standard Testing Procedure using API and Vitek. Completed testing and

documentation in accurate and timely manner.

• Performed special projects and protocols for laboratory investigation and

qualification of laboratory equipment, as well as characterization studies of

products and testing validations.

• Facilitated in Corrective and Preventive Action (CAPA) in laboratory

investigations and initiated obvious error checklists and algorithm testing for

product and laboratory investigations.

• Performed document writing and editing to assist in simplification and updates in

testing procedures and operating procedures in compliance with the FDA and

ISO.

• Performed monthly autoclave challenges using spore strips, crushable and glass

vials.

• Served as training coordinator and mentor and participated in training new

technicians.

• Prepared media and performed Growth Promotion and Media Inhibition Testing.

• Maintained and calibrated laboratory equipment per Good Manufacturing

Practice (GMP), served as back-up in Chemistry lab. Certified in pH and Total

Organic Carbon Testing.

Consolidated Medical Laboratories - Lake Bluff, IL. 1999 - 2000

Senior Laboratory Technician

• Performed clinical laboratory testing such as: gram staining, urine, ova, parasites

testing, C. diff, Herpes, TB, HIV, and Hepatitis testing using vidas, Imx, and

Commander platforms.

Alra Laboratories - Gurnee, IL. 1991 - 1999

Microbiology Technician

• Performed Microbial Testing on raw materials and finished products and routine

Microbial GMP testing and media preparation and growth promotion testing.

EDUCATION

Lyceum Northwestern University: Philippines – B.S. Medical Technology

Contact this candidate